U.S. ENVIRONMENTAL PROTECTION AGENCY 

ft 

~EPA PRElVIANUF A CTURE 

NOTICE 

Form Approved OJviB. No. 2070-0012. Approval Expires 10-31-96. 

AGENCY USE ONLY Date of rece1pt 

ES 

03 NOV -5 M1 6: 07 

Company Sanitized 

Llll~l Ul\.- lVLllJ IIUIJJV\..1 UJ pace~ 

in the Premanufacture Notice ) 

RUCTIONS 

You must provide all infonnation requested in this form to the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates if you do 

not have actual data. 

Before you complete this form. you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available from the Toxic 

Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603). 

lf a user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember. 

your user fee ID number must also appear on your corresponding fee remittance, which is sent to EPA, HQ Accounting Operations Branch (PM-226). P 0. 

360399M, Pittsburgh. PA 15251-6399. Attn. TSCA User fee. 

Part 1- GENERAL INFORMATION 

You must provtde the currently correct Chemical Abstracts (CA) !'-:arne of the new 

chenlicaJ substance. n·en 1f you claim the identity as confident..ia1. You may authorize 

another person to submit chemical identity information for you. but your submission will 

not be complete and the review will not begm until EPA receives this information. A letter 

in support of your submission should reference your TS user fee identification number. 

You must submit an original and two copies of this notice including all test data If you 

cl3imed ~ny information ;15 confidenti;1l. a single s~nitized copy must also be submitted. 

Pan II-HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

If !.here are seYeral manufJcture. processing. or use operations to be described in Part II, 

sections A and B of this notice. reproduce Lhe sections as needed. 

Part III- LIST OF ATTAClll\lENTS 

Altach additional sheets if there is not enough space to answer a question fully. Label each 

continuation sheet "·ith the corresponding section heading. In Part III, list these 

attachments, any test data or other data and any optional information included in the notice. 

OPTIONAL INFORMATION 

You may include any information that you want EPA to consider in evaluating the new 

substance. On page II of this form space has been provided for you to described 

pollution prevention and recycling information you may have regarding the new substance. 

So-called "binding" boxes are included throughout this form for you to indicate your 

willingness to be bound to certain staterr.ents you make in thjs section, such as use, 

production volume, protective equipment . Ths option is intended to reduce delays that 

routinely accompany the development of consent orders or Significant New Use Rules. 

Except in the case of exemption applications (such as TMEA, LYE, LOREX) where 

certain information provided in such notification is binding on the submitter when the 

Agency approves the exemption application. checking a binding box in this notice does not 

by itself prohibit the submitter from later deviating from the information (except chemical 

identity) reported in the form 

CONFIDENTIALITY CLAIMS 

You may claim any information in Lhis notke as confidential To assert a claim on the 

form. mark (X) the confidential box next to the information U1at you claim as confidentiaL 

To assert a claim in an attachment. circle or bracket the informal ion you claim as 

confidential. Jf you claim information in lhe notices as confidential you must also provide 

a sanitized version of the notice. (including attactunents). For additional instructions on 

claiming information as confidential. read the 1nstructions Manual. 

~1ark (x) if any information in this notice is claimed as confidentiaL 

EPA FORM 7710-25 (Rev. 5-95) 

TEST DATA AND OTHER DATA 

You are required to submit all test data in your possession or control and to 

provide a description of all other data known to or reasonably ascertainable by 

you. if these data are related to the health and environmental effects on the 

manufacture. processing, distribution in commerce, use, or disposal of the new 

chemical substance. Standard literature CJtations may be submitted for data in the 

open scientific literature. Complete test data (written in Enelish), not sununaries 

of data, must be submitted if they do not appear in the open literature. You should 

clearly identify whether test data is on the substance or on an analog. Also, the 

chemical composition of the tested material should be characterized. Following 

are examples of test data and other data. Data should be submitted according to 

the requirements of §720.50 of the Premanufacture Notification Rule (40 CFR 

Part 720) 

Test Data (Check 1Below any included in this notice) 

Environmental fate data ~ Yes• 

Health effects data ~ Yes 

Environmental effects data 0 Yes 

Physicai!Chemical Properties* ~ Yes 

Other data ~ Yes 

Risk assessments [8l 

Structurelacti,·ity relationships[8l 

Test data not in the possession 

or control of the submitterO 

A physical and chemical properties worksheet is located on the last page of this form. 

TYPE OF NOTICE (Check Only One) 

~ PMN (Premanufacture Notice) 

D INTERMEDIATE PMN (submitted in sequence with final product PMN) 

D 

D 

D 

SNUN (Significant New llse Notice) 

Th1EA (Test Marketing Exemption Application) 

LYE (Low Volume Exemption)@ 40 CFR 723.50(c)(!) z 

o 

D LOREX (Low Release/Low Exposure Exemption) @ 40 CFR 723.50(c~ 

D LYE Modification 

IS THIS A CONSOLIDATED PMN7 

# of chemicals 

(Pre notice Communication# re 

I 

D 

D 

LOREX Modification 

Yes 

0" 

Replaces previous editions of EPA Fonn 7710-25. 
Public reporting burden for this collection of information is estimated to average II 0 hours per response, including time for reviewing -

instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 

information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for 

reducing this burden, to Chief, Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M. St., S.W., Washington, D.C. 

20460; and to the Office of Management and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C. 20503. 

CERTIFICATION 

I certify that to the best of my knowledge and belief: 

l. The company named in Part I, section A, subsection 1a of this notice form intends to manufacture or import for a 

commercial purpose, other than in small quantities solely for research and development, the substance identified in Part I, 

Section B. 

2. All information provided in this notice is complete and truthful as of the date of submission. 

3. I am submitting with this notice all test data in my possession or control and a description of all other data known to or 

reasonably ascertainable by me as required by § 720.50 of the Premanufacture Notification Rule. 

Additional Certification Statements: 

If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, check the following user fee certification 

statement that applies: 

~ The Company named in Part I, Section A has remitted the fee of $2500 specified in 40 CFR 700.45(b), or 

D The Company named in Part I, Section A has remitted the fee of $1000 for an Intermediate PMN (defined @ 40 CFR 

700.43) in accordance with 40 CFR 700.45(b), or 

D The Company named in Part I Section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 

in accordance with 40 CFR 700.45(b ). 

If you are submitting a low volume exemption (LVE) application in accordance with 40 CFR 723.50(c)(1) or a Low release 

and low exposure exemption (LoRex) application in accordance with 40 CFR 723.50(c)(2), ch,eck the following certification 

statements: 

D The manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial 

purposes, other than in small quantities solely for research and development, under the terms of 40 CFR 723.50. 

D The manufacturer is familiar with the terms of this section and will comply with those terms; and 

D The new chemical substance for which the notice is submitted meets all applicable exemption conditions. 

D If this application is for an LYE in accordance with 40 CFR 723.50(c)(l), the manufacturer intends to commence 

manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30 day 

review period. 

The accuracy of the statements you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical substance 

described herein. Any knowing and willful misinterpretation is subie~Ho criminal penalty pursuant to 18 USC 1001. 

Signature of agent - (if applicable) Date 

EPA FORM 7710-25 (Rev. 5-95) Page 2 

Confidential 
I a. Person Name of authorized official 

Submitting 

Notice (in U.S.) 

b. Agent (if 

applicable) 

Company 

1669 Lake Avenue 

City, State, ZIP Code 

Company 

Mailing address (number and street) 

City, State, ZIP Code 

Position 

Manager, Kodak Park Site Vice President 

Position 

Telephone Area Code Number 

c. If you are submitting this notice as part of a joint submission, mark (X) this box.----------------------~ • 

Joint Submitter (if 

applicable) 

2. Technical 

Contact (in 

U.S.) 

Name of authorized official 

Company 

Mailing address (number and street) 

City, State, ZIP Code 

Name of authorized official 

Mr. James R. Humphreys 

Company 

Eastman Kodak Company 

Mailing address (number and street) 

Position 

Telephone Area Code 

Position 

Section 5 Technical Contact 

Health, Safety, and Environment, Bldg. 320, Kodak Park 

3. 

4. 

5. 

6. 

City, State, ZIP Code 

Rochester, New York 14652-6267 

If you have had a pre notice communication (PC) concerning this notice and 

EPA assigned a PC Number to the notice, enter ;;;th;,;,e,;:;nu:;;;m:.;;b:..:e;,;,r. ____ + 

If you previously submitted an exemption application for the chemical 

substance covered by this notice, enter the exemption number assigned by 

EPA. If you previously submitted a PMN for this substance enter the PMN 

number assigned by EPA (i.e. withdrawn or incomplete). 

If you have submitted a notice of Bona fide intent to manufacrure or import 

for the chemical substance covered by this notice, enter the notice number 

assigned by EPA. 

I. 

Type of Notice - Mark (X) 

D 

Manufacture 

Only 

Binding Option 

Mark 

EPA FORM 7710-25 (Rev. 5-95) 

Telephone 

Mark (X) 

if none 

L-99-0024 Mark(X) 

if none 

D 

Page 3 

Import 

Only 

Mark (X) 

if none 

Binding Option 

Number 

722-4749 

D 

Both 

Confidential 

• 

• 

II 
If another person will submit chemical identity information for you (for either Item I or 2), mark (X) the box at the right. 

the and address of that in a sheet. 

I. Class I or 2 chemical substances (for definitions of class I and class 2 substances, the Instructions Manual) 

a. Class of substance - Mark (X) ~ Class I or 2 Class 2 

b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances. 

substance based on 

Confidential 

For Class I substances a CA Index Name must be provided. For Class 2 substances either a CA Index Name orCA Preferred Name must X 

be provided, which ever is appropriate based on CA 9CI nomenclature rules and conventions). 

c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice: (check 

one). 

~ Method I (CAS Inventory Expert Service- a copy of the Identification 0 Method 2 (Other Source) 

report obtained from the CAS Inventory Expert Services must be 

submitted as an attachment to this See 18 

d. Molecular formula and CAS Registry Number (if a number already exists for the substance) 

CAS# 

e. For a class I substance, provide a complete and correct chemical structure diagram. For a class 2 substance - (I) List the immediate 

precursor substances with their respective CAS Registry Numbers. (2) Describe the nature of the reaction or process. (3) Indicate the 

range of composition and the typical composition (where appropriate). (4) Provide a correct representative or partial chemical structure 

diagram, as complete as can be known, if one can be reasonably ascertained. 

attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page4 

X 

X 

X 
For a class 2 substance- (I) List the immediate precursor substances with their respective CAS Registry Numbers. (2) Describe the nature of the reaction or 

process. (3) Indicate the range of composition and the typical composition (where appropriate). 

e. (I) List the immediate precursor substances with their respective CAS Registry Numbers 

Name (CAS#) 

Not applicable 

e. (2) Describe the nature of the reaction or process 

Not applicable 

e. (3) Indicate the range of composition and the typical composition (where appropriate) 

Not applicable 

D Mark (X) this box if you attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 5 

Confdential 
a. Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture. 

Indicate maximum weight percent of low molecular weight species (not including residual monomers, reactants, or solvents) below 500 and 

below I ,000 absolute molecular weight of that composition. 

Confidential 

Describe the methods of measurement or the basis for your estimates: GPC 0 Other 0: (Specify) __ Not applicable __ 

i) lowest number average molecular weight: _ Not applicable_ 

ii) maximum weight % below 500 molecular weight: ___ Not applicable_ 

iii) maximum weight % below I 000 molecular weight: ___ Not applicable_ 

attach a continuation sheet. 

You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark (X) the 

"Confidential" box next to any item you claim as confidential 

(I) Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the manufacture of 

the polymer. 

(2) Mark (X) this column if entry in column (I) is confidential. 

(3) Indicate the typical weight percent of each monomer or other reactant in the polymer. 

(4) Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the polymer 

description on the TSCA Chemical Substance Inventory. 

(5) Mark (X) this column if entries in columns (3) and (4) are confidential. 

(6) Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for 

commercial purposes. 

Mark this column if is confidential. 

Confi- Typical 

Not applicable % 

% 

% 

% 

% 

o/o 

o/o 

c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice (check one). 

0 Method I (CAS Inventory Expert Service- a copy of the identification report 0 Method 2 (other source) 

obtained from CAS Inventory Expert Service must be submitted as 

as attachment this 

d. The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers. 

Not 

e. Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained. 

Not applicable 

attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 6 

Confi-

% 

% 

% 

% 

% 

% 

o/o 
Part I-- GENERAL INFORMATION-- Continued 

Section B --CHEMICAL JUI'.N 111 r IN!' UKJViA TION Continued 

3. Impurities 

(a) Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose. Provide 

the CAS Registry Number if available. If there are unidentified impurities. enter "unidentified." 

(b) - Estimate the maximum weight% of each impurity. If there are unidentified impurities, estimate their total weight%. 

Impurity and CAS Registry Number Maximum Confipercent dential 

(a) (b) 

Acetone [67 -64-1] 0.001 o/o 

Methanol [67-56-1] 0.01 o/o 

o/o 

% 

% 

% 

o/o 

[ ] Mark (X) this box if you attach a continuation sheet. 

4. Synonyms- Enter any chemical synonyms for the new chemical identified in subsection I or 2. Contidential 

X 

D Mark (X) this box if you attach a continuation sheet. 

5. Trade identification- List trade names for the new chemic;li substance identified in subsection I or 2. 

None 

D Mark (X) this box if you attach a continuation sheet. 

6. Generic chemical name - If you claim chemical identify as confidential, you must provide a generic name for your substance that reveals 

the specific chemical identity of the new chemical substance to the maximum extent possible. Refer to the 

TSCA Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names. 

Substituted amino ethane sulfonic acid salt 

_0 Mark (X) this box if you attach a continuation sheet. 

7. Byproducts- Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new chemical substance. Provide the CAS Registry 

Number if available. 

Byp[~uct CASR Number Conti-

(2) dential 

Sodium hydroxide 1310-75-2 

[ J Mark (X) this box if you attach a continuation_sheet 

EPA FORM 7710-25 (Rev 5-95) Page 7 
Part I -- GENERAL INFORMATION -- Continued 

Section C --PRODUCTION, IMPORT, AND USE INFORMATION: 

Mark (X) the "Confidential" box next to any item you claim as confidential. 

1. Production volume-- Estimate the maximum production volume during the first 12 months of production. Also estimate the maximum 

production volume for any consecutive 12-month period during the first three years of production. Estimates should be on 100% new chemical 

substance basis. For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower production volume than 

10,000 kg/yr. specify the volume and mark (x) in the binding box. If granted, you are bound to this volume 

Maximum first 12-month production (kg/yr) Maximum 12-month production (kg/yr) Conti- Binding 

(100% new chemical substance basis) (100% new chemical substance basis) dential Option 

Mark (x) 

1200 1200 

2. Use Information -- You must make separate confidentiality claims for the description of the category of use, the percent of production volume 

devoted to each category, the formulation of the new substance, and other use information. Mark (X) the "Confidential" Box next to any item 

you claim as confidential. 

a. (I) -- Describe each intended category of use of the new chemical substance by function and application .. 

(2) -- Mark (X) this column if entry column (I) is confidential business information (CBI). 

(3) -- Indicate your willingness to have the information provided in column (I) binding. 

(4) -- Estimate the percent of total production for the first three years devoted to each category of use. 

(5) -- Mark (X) this column if entry in column (4) is confidential business information (CBI). 

(6) -- Estimate the percent of the new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for 

commercial purposes at sites under your control associated with each category of use. 

(7) -- Mark (X) this column if entry in column (6) is confidential business information (CBI). 

(8) -- Indicate %of product volume expected for the listed "use" sectors. Mark more than one box if appropriate. Mark (X) to indicate 

your willingness to have the use type provided in (8) binding. 

(9) -- Mark (X) this column if entrv(ies) in column (8) is (are) confidential business infotmation (CBI). 

Category of use (I) CBI Binding Produc- CBI %in CBI % of substance expected per use CBI 

Option tion o/o Form- (8) 

(by function and application i.e. a dispersive dye ~lark (x) ulation Site- Con-* Indus- Com- Binding 

for finishino. polyester fibers) (2) (3) (4) (5) (6) (7) limited sumer trial mercia! Option (9) 

X 100% <2% o/o 100% 

% % 

% % 

% % 

% % 

% % 

* If you have identified a "consumer" use, please provide on a continuation sheet a detailed description of the use(s) of this chemical substance in consumer products. 

In addition include estimates of the concentration of the new chemical substance as expected in consumer products and describe the chemical reactions by which 

this substance loses its identity in the consumer product. 

D Mark (X) this box if you attach a continuation sheet. 

b. Generic If you claim any category of use description in subsection 2a as confidential, enter a generic description of that category. Read the 

use Instructions Manual for examples of generic use descriptions. 

description 

Contained use in digital and imaging products 

D Mark (X) this box if you attach a continuation sheet. 

3. Hazard Information-- Include in the notice a copy of reasonable facsimile of any hazard warning statement. labeL material safety data sheet, or other Binding 

information which will be provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices Option 

Mark (xl 

for the safe handing, transport, use, or disposal of the new substance. List in part Ill hazard information you include. 

[2J Mark (X) this box if you attach hazard information. S e. e.. ?a.C\e ~ 1.. ~-"L 'l 

"' EPA FORM 7710-25 (Rev. 5-95) Page 8 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (X) box next to any item you 

claim as 

Complete section A for each type of manufacture, processing, or use operation involving the new chemical substance at industrial sites you 

control. Importers do not have to complete this section for operations outside the U.S.; however, you may still have reporting requirements if 

there are further industrial after i You must describe these . See instructions manual 

of the site at which the will occur. dential 

Kodak Park 

Site address (number and street) 

1669 Lake Avenue 

City, County, State, ZIP code 

Rochester, Monroe, New York 14652 

If the same operation will occur at more than one site, enter the number of sites. Identify the 

additional sites on a continuation sheet, and if any of the sites have significantly different 

production rates or operations, include all the information requested in this section for those 

sites as attachments. 

b. 

I. Batch 

2. Continuous 

attach a continuation sheet. 

Maximum kg/batch (IOO'k new chemical 1 Hours/batch 

substance) I 

300 I 

Maximum kg/day (100% new chemical 1 Hours/day 

substance) 1 

72 

d. Process description Mark (X) to indicate your willingness to have your process description binding. 

Use 

1 Batches/year 

I 

: Days/year 

4 

X 

(I) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon 

drum, rail car, tank truck, etc.). 

(2) Provide the identity , the approximate weight (by kg/day or kg/batch on a I 00% new chemical substance basis), and entry point of all starting materials and 

feedstocks (including reactants, solvents, catalysts, etc.), and of all products. recycle streams, and wastes. Include cleaning chemicals (note frequency if not 

used daily or per batch.). 

(3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. 

attach a continuation sheet. See 20-21 

EPA FORM 7710-25 (Rev. 5-95) Page 9 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued 

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued 

2. Occupational Exposure·· You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical substance, 

number of works exposed, and duration of activity. Mark (X) the "Confidential" box next to any item you claim as confidentiaL 

(I)-- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the substance. 

(2) --Mark (X) this column if entry in column (I) is confidential business information (CBI). 

(3) --Describe any protective equipment and engineering controls used to protect workers. 

(4) and (6) --Indicate your willingness to have the information provided in column (3) or (5) binding. 

(5) --Indicate the physical form(s) of the new chemical substance (e.g., solid: crystal, granule, powder, or dust) and% new chemical substance (if part of a 

mixture) at the time of exposure. 

(7) --Mark (X) this column if entry in column (5) is confidential business information (CBI). 

(8) --Estimate the maximum number of workers involved in each activity for all sites combined. 

(9) --Mark (X) this column if entry in column (8) is confidential business information (CBI). 

(I 0) and (II) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year. 

(12) -- Mark (X) this column if entries in columns (I 0) and (II) are confidential business information (CBI). 

Worker activity CBI Protective Equipment/ Binding Physical fonns(s) Binding CBI #of CBI Maximum duration CBI 

(i.e., bag dumping, filling drums) Engineering Controls Option and% new Option Workers Hrs/day Days/yr Mark (x) substance Mark (x) Exposed 

(I) (2) (3) (4) (5) (6) (7) (8) (9) (10) (II) (12) 

Cleaning of filtering and See pages 23-27 Damp solid 2 0.5 4 

collection equipment <0.1% 

Loading the collection See pages 23-27 Slurry 2 0.3 4 

equipment <30% 

Loading the drying equipment See pages 23-27 Damp solid 2 1.0 4 

-90% 

Loading the container See pages 23-27 Dry solid 2 1.0 4 

100% 

% 

~ Mark (X) this box if you attach a continuation sheet. See pages 23-27 

3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new chemical substance 

released and other release and disposal information. Mark (X) the "Confidential" box next to each item you claim as confidential. 

(I) --Enter the number of each release point identified in the process description, part II, section A, subsection I d(3). 

(2) --Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch). 

(3) --Mark (X) this column if entries in columns (I) and (2) are confidential business information (CBI). 

(4) --Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify)) to 

which the new substance will be released from that release point. 

(5) --a. Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. For releases 

disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. On a continuation sheet, for 

each site describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate 

the amount released to the environment after control technology (in kg/day). 

(6) --Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI). 

(7) --Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or 

NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES #is confidential business information (CBI). 

Release Amount of new substance CBI Media of Control technology and efficiency (you may wish to optionally attach efficiency data) CBI 

Number released release 

(I) (2a) (2b) e g. stack au I Binding 

(3) (4) (5a) I Mark (X) (5b) (6) I 

1 None <2 incineration container Incineration (>99.99% ORE) I None I 

kg/batch I 

I 

2 None <0.5 recovery tank Solvent Recovery/Incineration (>99.99% ORE) I None I 

kg/batch I 

I 

3 None <1.0 industrial sewer Biological treatment/Incineration (>99.9% ORE) I <0.5 kg/day I 

kg/batch I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

(7) Mark (X) the 0 POTW provide name(s) below: CBI ~Navigable 0 Other- Specify provide NPDES # CBI 

- destination(s) of waterway 

releases to water. NY -000-1643 

~ Mark (X) this box if you attach a continuation sheet. See pages 15 and 43 

EPA FORM 7710-25 (Rev. 5-95) Page 10 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (X) the "Confidential" box next to any item you 

claim as confidential 

Complete section A for each type of manufacture, processing, or use operation involving the new chemical substance at industrial sites you 

control. Importers do not have to complete this section for operations outside the U.S.; however, you may still have reporting requirements if 

there are further industrial · after You must describe these ons. See instructions manual 

of the site at which the will occur. dential 

Name 

Kodak Park 

Site address (number and street) 

1669 Lake Avenue 

City, County, State, ZIP code 

Rochester, Monroe, New York 14652 

If the same operation will occur at more than one site, enter the number of sites. Identify the 

additional sites on a continuation sheet, and if any of the sites have significantly different 

production rates or operations, include all the information requested in this section for those 

sites as attachments. 

Mark (X) this box if 

b. Type--

Mark (X) 

I. Batch 

2. Continuous 

attach a continuation sheet. 

Maximum kg/batch (100% new chemical 1 Hours/batch 

substance) r 

14 I 

Maximum kg/day (100% new chemical : Hours/day 

substance) 1 

120 

d. Process description Mark (X) to indicate your willingness to have your process description binding. 

Use 

1 Batches/year 

86 : Days/year 

X 

(I) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon 

drum, rail car, tank truck, etc.). 

(2) Provide the identity, the approximate weight (by kg/day or kg/batch on a I 00% new chemical substance basis), and entry point of all starting materials and 

feedstocks (including reactants, solvents. catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not 

used daily or per batch.). 

(3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. 

attach a continuation sheet. See 22 

EPA FORM 7710-25 (Rev. 5-95) Page II 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE-- Continued 

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued 

2. Occupational Exposure-- You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical substance, 

number of works exposed, and duration of activity. Mark (X) the "Confidential" box next to any item you claim as confidential. 

(I)-- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the substance. 

(2) --Mark (X) this column if entry in column (1) is confidential business information (CBI). 

(3) --Describe any protective equipment and engineering controls used to protect workers. 

(4) and (6) --Indicate your willingness to have the information provided in column (3) or (5) binding. 

(5) --Indicate the physical form(s) of the new chemical substance (e.g., solid: crystal, granule, powder, or dust) and% new chemical substance (if part of a 

mixture) at the time of exposure. 

(7) --Mark (X) this column if entry in column (5) is confidential business information (CBI). 

(8) --Estimate the maximum number of workers involved in each activity for all sites combined. 

(9) --Mark (X) this column if entry in column (8) is confidential business information (CBI). 

(10) and (II)-- Estimate the maximum duration of the activity for any worker in hours per day and days per year. 

(12) -·Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI). 

Worker activity CBI Protective Equipment/ Binding Physical forms(s) Binding CBI #of CBI Maximum duration CBI 

(i.e., bag dumping, filling drums) Engineering Controls Option and% new Option Workers Hrs/day Days/yr Mark (x) substance Mark (x) Exposed 

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (I I) (12) 

Weighing of the chemical See pages 23-27 Dry solid 6 0.1 20 

100% 

Loading the milling vessel See pages 23-27 Dry solid 6 0.1 20 

100% 

Cleaning of filtration equipment See pages 23-27 Damp solid 6 0.1 20 

<5% 

Loading the ink processing See pages 23-27 Dispersion 6 0.1 20 

vessel <8% 

Loading the containers See pages 23-27 Dispersion 6 1 20 

<2% 

~ Mark (X) this box if you attach a continuation sheet. See ]!_ages 23-27 

3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new chemical substance 

released and other release and disposal information. Mark (X) the "Confidential" box next to each item you claim as confidential. 

(I) --Enter the number of each release point identified in the process description, part II, section A, subsection I d(3). 

(2) --Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch). 

(3) --Mark (X) this column if entries in columns (I) and (2) are confidential business information (CBI). 

(4) --Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify)) to 

which the new substance will be released from that release point. 

(5) --a. Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. For releases 

disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. On a continuation sheet, for 

each site describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate 

the amount released to the environment after control technology (in kg/day). 

(6) --Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI). 

(7) --Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or 

NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES #is confidential business information (CBI). 

Release Amount of new substance CBI Media of Control technology and efficiency (you may wish to optionally attach efficiency data) CBI 

Number released re]ease 

(I) (2a) (2b) eg. st:w.:k mr I Binding 

(3) (4) (Sa) I Mark (X) (5b) (6) I 

1 None <0.05 incineration container Incineration (>99.99% ORE) I None I 

kg/batch I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

I 

(7) Mark (X) the 0 POTW provide name(s) below: CBI 0 Navigable 0 Other - Specify provide NPDES # CBI 

r----

destination(s) of waterway 

releases to water. 

~ Mark (X) this box if you attach a continuation sheet. See page 15 

EPA FORM 7710-25 (Rev. 5-95) Page 12 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued 

Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS 

Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control. Importers do not have to complete this 

section for operations outside the U.S.; however, you must report any processing or use activities after import. See the Instructions Manual. Complete a separate 

section B for each type of processing, or use operation involving the new chemical substance. If the same operation is performed at more than one site describe the 

typical operation common to these sites. Identify additional sites on a continuation sheet. 

1. Operation Description-- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential. 

(I)-- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon 

drums, rail cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. (2) --Provide the identity, the approximate weight 

(by kg/day or kg/batch, on an I 00% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all 

products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) -- Identify by number the points of release, 

including small or intermittent releases, to the environment of the new chemical substance. (4) Please enter the# of sites (remember to identify the locations of 

these sites on a continuation sheet): See page 19 

i ,; J .. r. ) ~ ·~ f1 ' .. , , .. ,.\-\ 1 ... • I ( l •, . l . ' ' I I i ; r ' ! : ,, ; .' • . , , I, • " #of sites 

;. .~ ·,. ~ • r s ( .. i ~J ~ .~, 'f I ' I j 

' I ' i ',.< 

Inkjet Renew 

17642 N. 251

h Ave. / / 

Phoenix, Arizona 85023 

Water [7732-18-5] B"" 

Cleaning - Drums ~ 1 II"" 

1/ 

A 

~t 

/ / 

500-ml 

bottles / 

D Mark (X) this box if you attach a continuation sheet. 

2. Worker Exposure/Environmental Release 

(I)-- From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described. 

(2) --Estimate the number of workers exposed for all sites combined. 

(4) --Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year. 

(6) --Describe physical form of exposure and %new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to 

protect workers. 

(7) --Estimate the percent of the new substance as formulated when packaged or used as a final product. 

(9) --From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified. 

(10) --Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/batch). 

(12) --Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, POTW, or other 

(specify) and control technology, if any, that will be used to limit the release of the new substance to the environment. 

(14) -- Identify byproducts which may result from the operation. 

(3), (5), (8), (II), ( 13) and ( 15) -- Mark (X) this column if any of the proceeding entries are confidential business information (CBI). 

Letter #of CBI Duration CBI Protective Equip. I %in CBI Release Amount of CBI Media of Release CBI 

of Workers of Engineering Controls/ Form- Number New &Control 

Act- Exposed Exposure Physical Form and % ulation Substance Technology 

ivity new substance Released 

(I) (2) (3) (4a) I (4b) (5) (6) (7) (8) (9) (lOa) I (lOb) (I I) (12) (13) 

A 5 6 I 

I 40 Dispersion (<2%) <2% 1 None : <0.001 Sewer I 

I 

See MSDS on pages 23-27 I 

I 

kg 

B 5 0.1 I 40 Dispersion (<2%) <2% 1 None I <0.001 Sewer I 

I See MSDS on pages 23-27 : kg I I 

I I 

I I 

I I 

I I 

I I 

I I 

I I 

I I 

(14) -- Byproducts: (15) 

None 

D ·Mark (X) this box if you attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 13 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE-- Continued 

Section B --INDUSTRIAL SITES CONTROLLED BY OTHERS 

Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control. Importers do not have to complete this 

section for operations outside the U.S.; however, you must report any processing or use activities after import. See the Instructions Manual. Complete a separate 

section B for each type of processing, or use operation involving the new chemical substance. If the same operation is performed at more than one site describe the 

typical operation common to these sites. Identify additional sites on a continuation sheet. 

1. Operation Description-- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential. 

(I)-- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon 

drums, rail cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. (2) --Provide the identity, the approximate weight 

(by kg/day or kg/batch, on an 100% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all 

products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) --Identify by number the points of release, 

including small or intermittent releases, to the environment of the new chemical substance. (4) Please enter the# of sites (remember to identify the locations of 

these sites on a continuation sheet): See page 19 

CONFIDENTIAL 1 

#of sites 

D Mark (X) this box if you attach a continuation sheet. 

2. Worker Exposure/Environmental Release 

(I)-- From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described. 

(2) --Estimate the number of workers exposed for all sites combined. 

(4) --Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year. 

(6) --Describe physical form of exposure and o/o new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to 

protect workers. 

(7) --Estimate the percent of the new substance as formulated when packaged or used as a final product. 

(9) --From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified. 

(I 0) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/batch). 

(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, P01W, or other 

(specify) and control technology, if any, that will be used to limit the release of the new substance to the environment. 

(14) --Identify byproducts which may result from the operation. 

(3 ), (5), (8), (I I), (13) and ( 15) -- Mark (X) this column if any_ of the proceeding entries are confidential business information (CBJ). 

Letter #of CBI Duration CBI Protective Equip. I %in CBI Release Amount of CBI Media of Release CBI 

of Workers of Engineering Controls/ Fonn- Number New &Control 

Act- Exposed Exposure Physical Form and o/o ulation Substance Technology 

ivity new substance Released 

(I) (2) (3) (4a) I (4b) (5) (6) (7) (8) (9) (lOa) I (lOb) (II) (12) (13) 

X I X X I X X I I 

I I 

I I 

X I X X I 

I I 

I I 

I I 

I I 

I I 

I I 

I I 

(14) -- Byproducts: (15) 

None 

0 Mark (X) this box if you attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 14 
OPTIONAL POLLUTION PREVENTION INFORMATION 

To claim information in this section as confidential circle or bracket the specific information that you claim as confidential. 

In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce 

or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal 

of the PMN substance. Please include new information pertinent to po11ution prevention, including source 

reduction, recycling activities and safer processes or products available due to the new chemical substance. 

Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological 

modification, process and procedure modification, product reformulation, raw materials substitution, and/or 

inventory control. Recycling refers to the reclamation of useful chemica] components from wastes that would 

otherwise be treated or released as air emissions or water discharges, or land disposal. Descriptions of po11ution 

prevention, source reduction and recycling should emphasize potential risk reduction subsequent to compliance 

with existing regulatory requirements and can be either quantitative or qualitative. The EPA is interested in the 

information to assess overa11 net reductions in toxicity or environmental releases and exposures, not the shifting 

of risks to other environmental media or non-environmental areas (e.g., occupational or consumer exposure). In 

addition, information on the relative cost or performance characteristics of the PMN substance to potential 

alternatives may be provided. 

All information provided in this section will be taken into consideration during the review of this 

substance. See Instructions Manual and Pollution Prevention Guidance manual for guidance and 

examples. 

Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in the 

volume manufactured; (3) a reduction in the generation of waste materials through recycling, source reduction or other means; (4) a 

reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product performance, a decrease in 

the cost of production and/or improved operation efficiency of the new chemical substance in comparison to existing chemical 

substances used in similar application; or (6) the extent to which the new chemical substance may be a substitute for an existing 

substance that poses a greater overall risk to human health or the environment. 

The stoichiometry was optimized to avoid using an unnecessary excess of starting materials and reagents. For all manufacturing 

operations (reaction, work-up) the quantity of volatile organic solvents will be kept at a minimum. Batch size has been maximized to 

reduce clean up waste. Drums containing starting materials are emptied thoroughly before recycling or incineration. Methanol 

distillates and acetone cleaning liquors are collected and distilled for reuse. 

WASTE MANAGEMENT 

KODAK PARK, ROCHESTER, N.Y. 

All wastes containing the notified substance are sent to control technologies prior to release to the environment. Aqueous wastes 

are sent to the company's on-site wastewater treatment facility (WWTU) that is operated in compliance with state and federal 

regulations. Selected solvents are purified and recycled. Non-recyclable organic wastes are combusted in the company's on-site 

rotary kiln incinerator that is also operated in compliance with state and federal regulations. Occasionally wastes may be sent off site 

for treatment at an approved contract facility or for metals reclamation. 

D Mark (X) this box if you attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 15 
Part III-- LIST OF ATTACHMENTS 

Attach continuation sheets for sections of the form and test data and other data (including physical/chemical properties and structure/activity 

information), and optional information after this page. Clearly identify the attachment and the section of the form to which it relates, if appropriate. 

Number consecutively the pages of the attachments. In the column below, enter the inclusive page numbers of each attachment. 

Mark (X) the "Confidential" box next to any attachment name you claim as confidential. Read the Instructions Manual for guidance on how to claim 

any information in an attachment as confidential. You must include with the sanitized copy of the notice form a sanitized version of any attachment 

in which vou claim information as confidential. 

# Attachment name Attachment Contipage number(s) dential 

1 Physical and Chemical Properties Worksheet 17 

2 CAS Inventory Expert Service Name 18 

3 Flow Diagram for Processing of the PMN Chemical 19 

4 Manufacturing Diagram 20-21 

5 Processing Diagram 22 

6 Material Safety Data Sheet 23-27 

7 Other Data: Estimations of Health and Environmental Fate and Effects 28-45 

8 Activated Sludge Respiration Inhibition Screening Test 46-59 

9 Acute Oral Toxicity Study in the Rat 60-78 

10 Purity Determination 79-97 

11 UltravioleWisible Light Spectroscopy 98-114 

12 Analysis by Infrared Spectroscopy 115-126 

13 Analysis by NMR Spectroscopy 127-140 

14 Physico-Chemical Properties with Respect to Solid Flammability 141-149 

15 Risk Assessment for Annex VIIC Notification 150-160 

0 Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number. 

EPA FORM 7710-25 (Rev. 5-95) Page 16 
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET 

To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data you provide and include it in the 

notice. Identify the property measured, the page of the notice on which the property appears, the value of the property, the unit in which the property 

is measured (as necessary), and whether or not the property is claimed as confidential. If the attachments are electronic, give the attachment number 

(found on page 12) at (b). The physical state of the neat substance should be provided. These measured properties should be for the neat (100% 

pure) chemical substance. Properties that are measured for mixtures or formulation should be so noted(% PMN substance in_). You are not 

required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplify review and ensure that confidential 

information is properly protected. You should submit this worksheet as a supplement to your submission of test data. This worksheet is not a 

substitute for submission of test data. 

Property Mark (X) Page Value(c) Measured or Confif number Estimate dential 

provided (b) (MorE) Mark (X) 

(d) 

Physical state of neat substance ~ 25 ~ (s) D (I) D (g) D 

M 

Vapor pressure D Not available D 

@Temperature oc 

Density/relative density D Not available D 

Solubility D Not available D 

@ Temperature oc 

Solvent 

Solubility in water @ Temperature D Not available D oc 

Melting temperature D Not available D 

Boiling/sublimation temperature @ D Not available D 

torr pressure 

Spectra ~ 98-140 

UVNis, IR, and NMR spectra ~ M 

Dissociation constant D Not available D 

Particle size distribution D Not available D 

Octanol I water partition coefficient D Not available D 

Henry's Law constant D Not available D 

Volatilization from water D Not available D 

Volatilization from soil D Not available D 

pH @ concentration D Not available D 

Flammability ~ 141-149 

Not highly flammable 

M ~ 

Explodability D Not available D 

Adsorption I coefficient D Not available D 

Other - Specify rg] 79-97 Purity 

M 

rg] 

Other- Specify rg] DSC rg] 160 M 

D Mark (X) this box if you attach a continuation sheet. 

F.ntf"r tht> :ltt:lchmf'nt n;~mp ;:mrl nnmhf'r 

17 
Inventory Expert Service 

A division of the American Chemical Society Phone: 800-63 1-1884, 614-447-3600 (ext. 2308) 

CONFlDENTlAL 

INVENTORY EXPERT SERVICE REPORT 

Fax: 614-+47-3747 

E-mail: answers@cas.org 

IES-ORDER NUMBER: 

CA IN!JEX NAME 

Please print the above CA Index Name on the appropriate page of your PMN. 

D If this box is checked, CAS has made correction(s) marked in red to 

your IES order. Please make the same correction(s) to your PMN before 

submitting it to the EPA. 

JCZ 

P.O. Box 33<43 Columbus, Ohio -432 I 0-033-4 
r·-

CONFIDENTIAl 

/9 
CONFIDENTIAL 

1_0 
· CONFIDENTIAL 

~I 
CONFIDENTIAL 

22 
Printed: 10/28/2003 

Report Version: 1 . 

000008201/F/USA 

Approval Date: 09/24/2002 

Page: 1/1 

~ffiTERIAL SAFETY DATA SHEET 

CONFIDENTIAl 

FOR USE ONLY WITHIN EAST~ KODAK COMPANY AND ITS SUBSIDIARIES. 

PRIOR APPROVAL IS REQUIRED FOR DISTRIBUTION OF THIS MSDS TO ANYONE OTHER THAN 

A KODAK EMPLOYEE. PHONE: THE KODAK ROCHESTER HEALTH, SAFETY AND ENVIRONMENT -

MSDS SERVICES GROUP (72-27178) 

1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION 

Product Name: -) 

Product Identification Number:~ 

Manufacturer/Supplier: EAST~ KODAK COMPANY and Subsidiaries 

MSDS Prepared by: MSDS Prepared by: Health, Safety and Environment 

Organization, Eastman Kodak Company, Rochester, NY 14652-6267. InCanada, call: 

(416) 766-8233. 

For Emergency Health, Safety & Environmental Information, call: 

United States: (585) 722-5151 

Canada: 1-800-363-1024 

Brazil: Knet 2686333, or phone number 12-332-6955 

_____....._ KAN Number: ' l 

Synonym(s): I - } 

Molecular Formula:( _____ \ .-/ 

Molecular Weight: 442.0 

IMPORTANT NOTE: This chemical is the subject of a Low Volume Exemption. 

2. COMPOSITION/INFOR~ffiTION ON INGREDIENTS 

Weight%- Component- (CAS Registry No.) 

3. HAZARDS IDENTIFICATION 

POWDERED MATERIAL MAY FORM EXPLOSIVE DUST-AIR MIXTURES 

CAN DECOMPOSE AT ELEVATED TEMPERATURES 

THE TOXICOLOGICAL PROPERTIES OF THIS MATERIAL HAVE NOT BEEN FULLY INVESTIGATED 

HEALTH HAZARD EVALUATION BASED, IN PART, ON DATA FOR A STRUCTURALLY SIMILAR 

MATERIAL 

MAY CAUSE BLOOD DISORDERS BASED ON ANIMAL DATA 

HARMFUL IF INHALED, ABSORBED THROUGH SKIN, OR SWALLOWED 

CAUSES SKIN AND EYE IRRITATION 

CAUSES SNEEZING 

Eastman Kodak Hazard Ratings: R-2, S-2, F-1, C-lT 

4. FIRST-AID MEASURES 

Inhalation: Move to fresh air. Treat symptomatically. Get medical attention if 

symptoms occur. 
Printed: 10/28/2003 

Report Version: 1 . 

000008201/F/USA 

Approval Date: 09/24/2002 

Page: 2/2 

MATERIAL SAFETY DATA SHEET 

Eyes: Immediately flush with plenty of water for at least 15 minutes. Get 

medical attention. 

Skin: Immediately flush with plenty of water for at least 15 minutes while 

removing contaminated clothing and shoes. Get medical attention if symptoms 

occur. Wash contaminated clothing before reuse. Destroy or thoroughly clean 

contaminated shoes. 

Ingestion: Only induce vomiting at the instruction of medical personnel. Call 

a physician or poison control center immediately. Never give anything by mouth 

to an unconscious person. 

5. FIRE FIGHTING MEASURES 

Extinguishing Media: Water spray, carbon dioxide (C02), dry chemical. 

Special Fire-Fighting Procedures: Wear self-contained breathing apparatus and 

protective clothing. Fire or excessive heat may produce hazardous 

decomposition products. 

Hazardous Combustion Products: Carbon dioxide, carbon monoxide, oxides of 

nitrogen, oxides of sulfur. 

Unusual Fire and Explosion Hazards: Powdered material may form explosive 

dust-air mixtures. Fire or high temperatures may cause decomposition. 

6. ACCIDENTAL RELEASE MEASURES 

Collect up and put ln a suitable container. Avoid generation of dust. Clean 

surface thoroughly to remove residual contamination. 

7. HANDLING AND STORAGE 

Personal Precautionary Measures: Avoid breathing dust. Avoid contact with 

eyes, skin, and clothing. Use with adequate ventilation. Wash thoroughly after 

handling. 

Prevention of Fire and Explosion: Keep away from heat. Powdered material may 

form explosive dust-air mixtures. Minimize dust generation and accumulation. 

Use with adequate ventilation. Keep away from sources of ignition. Refer to 

NFPA Pamphlet No. 654, "Prevention of Fire and Dust Explosions in the 

Chemical, Dye, Pharmaceutical, and Plastics Industries." Keep from contact 

with oxidizing materials. 

Storage: Keep container closed. 

8. EXPOSURE CONTROLS/PERSONAL PROTECTION 

Exposure Limits: Not established. 

Ventilation: Good general ventilation (typically 10 air changes per hour) 

should be used. ventilation rates should be matched to conditions. Use process 

enclosures, local exhaust ventilation or other engineering controls to 

maintain airborne levels to an acceptable level. Transfer of the dry solid 

will be done using local exhaust. 

Respiratory Protection: If engineering controls do not maintain airborne 

concentrations to an acceptable level, an approved respirator must be worn. 

Respirator type: N95 Particulate Filter. If respirators are used, a program 
Printed: 10/28/2003 

Report Version: 1 . 

000008201/F/USA 

Approval Date: 09/24/2002 

Page: 3/3 

MATERIAL SAFETY DATA SHEET 

fONFIDENTfAL 

should be instituted to assure compliance with OSHA Standard 29 CFR 1910.134. 

Eye Protection: Wear safety glasses with side shields (or goggles). 

Skin Protection: Wear impervious gloves and protective clothing appropriate 

for the risk of exposure. Recommended impervious materials: Neoprene rubber. 

Recommended Decontamination Facilities: Eye bath, washing facilities, safety 

shower 

9. PHYSICAL AND CHEMICAL PROPERTIES 

Physical Form: Solid 

Color: vJhite 

Odor: Odorless 

Specific Gravity (water = 1): Not available 

Vapor Pressure: Not available 

Vapor Density (Air = 1): Not available 

Volatile Fraction by Weight: Not available 

Melting Point: Not available 

Solubility in Water: Not available 

pH: Not applicable 

Flash Point: Not applicable, combustible solid 

10. STABILITY AND REACTIVITY 

Stability: Stable. Safe handling temperatures are dependent on specific 

conditions of use and are typically substantially below the onset temperature. 

Consult your technical safety experts. 

Exotherm onset temperature: 297°C by DSC 

Incompatibility: Strong oxidizing agents. 

Hazardous Polymerization: Will not occur. 

11. TOXICOLOGICAL INFORMATION 

Effects of Exposure: 

General: The toxicological properties of this material have not been fully 

investigated and its handling and use may be hazardous. Toxicity evaluation 

of thi~_chemical is based, in part, on a structurally similar chemical 

___ J). May cause blood disorders 

based on anlmal data. 

Inhalation: Harmful if inhaled. Causes sneezing. May cause irritation to the 

mucous membranes and upper respiratory tract. 

Eyes: Causes irritation. 

Skin: Harmful if absorbed through skin. Causes irritation. 

Ingestion: Harmful if swallowed. May cause irritation of the 

gastrointestinal tract. 

Acute Toxicity Data: 

Oral LD-50 (rat): > 2000 mg/kg 

Acute Toxicity Data for• 
Printed: 10/28/2003 

Report Version: 1 . 

000008201/F/USA 

Approval Date: 09/24/2002 

Page: 4/4 

MATERIAL SAFETY DATA SHEET 

( ______________________ __ 

CONFIDENTIAL 

Oral LD-50 (rat): 400-3200 mg/kg (target orga;~ effects: blood) 

Skin irritation: slight to moderate 

12. ECOLOGICAL INFORMATION 

Introduction: This environmental effects summary is written to assist in 

addressing emergencies created by an accidental spill which might occur during 

the shipment of this material, and, in general, it is not meant to address 

discharges to sanitary sewers or publically owned treatment works. 

Summary: Data for this material and chemically similar materials have been 

used to estimate the environmental impact of this material. However, this 

material, itself, has not been tested for environmental effects. It is 

expected to have the following properties: a moderate biochemical oxygen 

demand and may cause oxygen depletion in aqueous systems, a low potential to 

affect aquatic organisms, a moderate potential to affect secondary waste 

treatment microbial metabolism, a high potential to biodegrade (low 

persistence) with unacclimated microorganisms from activated sludge, a low 

potential to bioconcentrate. After dilution with a large amount of water, 

followed by secondary waste treatment, this material is not expected to cause 

adverse environmental effects. 

13. DISPOSAL CONSIDERATIONS 

Discharge, treatment, or disposal may be subject to national, state, or local 

laws. Incinerate. Since emptied containers retain product residue, follow 

label warnings even after container is emptied. 

14. TRANSPORT INFORMATION 

For 30 grams or less: 

United Nations 

UN Number: None, not regulated 

USA Department of Transportation (DOT) Hazardous Materials Classification: 

DOT (USA) Status: Not regulated 

DOT Hazardous Substance(RQ): No 

Marine Pollutant: No 

For other transportation information, call the Kodak Worldwide Transportation 

Hazmat Hot Line: (585) 722-2400 between 8 a.m. and 5 p.m. (Eastern Standard 

Time), Monday through Friday. 

15. REGULATORY INFORMATION 

- Material(s) known to the State of California to cause cancer: None 

- Material(s) known to the State of California to cause adverse reproductive 

effects: None 

- Carcinogenicity Classification (components present at 0.1% or more): 

- International Agency for Research on Cancer (IARC): None 

American Conference of Governmental Industrial Hygienists (ACGIH) None 

- National Toxicology Program (NTP): None 

- Occupational Safety and Health Administration (OSHA): None 
MATERIAL SAFETY DATA SHEET 

Printed: 10/28/2003 

Report Version: 1 . 

000008201/F/USA 

Approval Date: 09/24/2002 

Page: 5/5 

- Chemical(s) subject to the reporting requirements of Section 313 or Title 

III of the Superfund Amendments and Reauthorization Act (SARA) of 1986 and 

40 CFR Part 372: None 

16. OTHER INFORMATION 

US/Canadian Label Statements: 

WARNING' 

MAY CAUSE BLOOD DISORDERS BASED ON ANIMAL DATA 

HAR~lFUL IF INHALED, ABSORBED THROUGH SKIN, OR SWALLOWED 

CAUSES SKIN AND EYE IRRITATION 

POWDERED MATERIAL MAY FORM EXPLOSIVE DUST-AIR MIXTURES 

CAN DECOMPOSE AT ELEVATED TEMPERATURES 

CAUSES SNEEZING 

THE TOXICOLOGICAL PROPERTIES OF THIS !1ATERIAL HAVE NOT BEEN FULLY 

INVESTIGATED 

HEALTH HAZARD EVALUATION BASED, IN PART, ON DATA FOR A STRUCTURALLY SIMILAR 

MATERIAL 

Minimize dust generation and accumulation. 

Avoid breathing dust. 

Avoid contact with eyes, skin, and clothing. 

Keep container closed. 

Use with adequate ventilation. 

Wash thoroughly after handling. 

FIRST AID: If swallowed, only induce vomiting as directed by medical 

personnel. Never give anything by mouth to an unconscious person. Call a 

physician or poison control center immediately. If inhaled, move to fresh 

air. Treat symptomatically. In case of contact, immediately flush eyes and 

skin with plenty of water for at least 15 minutes while removing 

contaminated clothing and shoes. Get medical attention if symptoms occur. 

Wash contaminated clothing before reuse. Destroy or thoroughly clean 

contaminated shoes. 

Keep out of reach of children. 

Do not handle or use until safety precautions in Material Safety Data Sheet 

(MSDS) have been read and understood. 

Additional hazard precautions for containers greater than 1 gallon of liquid 

or 5 pounds of solid: 

Since emptied containers retain product residue, follow label warnings 

even after container is emptied. 

IN CASE OF FIRE: Use water spray, carbon dioxide (C02), dry chemical. 

IN CASE OF SPILL: Sweep or scoop up and remove. 

The information contained herein is furnished without warranty of any kind. 

Users should consider these data only as a supplement to other information 

gathered by them and must make independent determinations of suitability and 

completeness of information from all sources to assure proper use and disposal 

of these materials and the safety and health of employees and customers and 

the protection of the environment. 

17 
fONFIDENTIAL 

FINAL REPORT 

HAEL No..;j_ __ _ KAN:'~ J 

CAS No.:( ____ ,., CIN:~I 

P2-2003-015 

Page 1 of 18 

STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL 

FATE AND EFFECTS 

AUTHORS 

Rodney J. Boatman, Ph.D. 

Marianne P. 1-lirsch, Ph.D. 

TESTING FACll.JTY 

Toxicological Sciences Section 

Health and Environment Laboratories 

Eastman Kodak Company 

Rochester, NY 14652-6278 

USA 

STUDY SPONSOR 

Eastman Kodak Company 

STUDY COMPLETION DATE 

October 27, 2003 
P2-2003-0 15 

Page 2 of 18 

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This page has intentionally been left incomplete. 

zq 
SIGNATURE PAGE 

P2-2003-015 

Page 3 of 18 

STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL 

FATE AND EFFECTS 

Mari ne P. H1rsch, Ph.D. 

Senior Toxicologist 

Ecotoxicology 

Rodney J. Boarlnan, Ph.D., DABT 

Technical Associate 

Biochemica] and Analytical Toxicology 

Director 

Toxicological Sciences 

3o 

6!JcJu ,_.9.], JCC3 

Month/Day/Year 

Oc". 21>zoo~ 

Month/Day/Year 

aJk g.j,acoJ 

Month/Day/Y e;tl-

... 
TABLE OF CONTENTS 

CHEMICAL IDENTIFICATION INFORMATION 

Testing Facility 

Project Participants 

Sponsor 

Chemical Structure 

Chemical Characterization 

ABSTRACT 

INTRODUCTION AND METHODS 

RESULTS AND CONCLUSIONS 

REFERENCES 

APPENDIX 1. Output from the EPI Computer Program 

APPENDIX 2. Output from E-FAST Computer Program 

APPENDIX 3. Output from ECOSAR Computer Program 

APPENDIX 4. Output from the PBT Profiler 

APPENDIX 5. Output from the DEREKTM Computer Program 

31 

P2-2003-015 

Page 4 of 18 

Page 

Number 

5 

5 

5 

5 

5 

5 

6 

7 

7 

9 

10 

12 

13 

17 

18 
CONFIDENTIAl 

CHEMICAL IDENTIFICATION INFORMATION 

Testing Facility 

Toxicological Sciences 

Health and Environment Laboratories 

Eastman Kodak Company 

Rochester, New York 14652-6278 

USA 

Project Participants 

Report Authors: 

Sponsor 

Eastman Kodak Company 

Chemical Structure 

( 

Chemical Characterization 

Chemical Name: 

HAELNo.: 

KAN: 

Molecular Formula: 

Rodney J. Boatman, Ph.D. 

Marianne P. Hirsch, Ph.D. 

P2-2003-015 

Page 5 of 18 

) 

Molecular Weight: 

CAS No.: 

CIN: 

441.714 r L ___ _ 

L~-Neutral ~~~-----------J organics-acid 

Sl\1ILES: 

Classification (ECOSAR): 
fONFIDENTIAL P2-2003-015 

Page 6 of 18 

STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL 

FATE AND EFFECTS 

HAELNo.: KAN: 

CAS No.~ CIN: 

ABSTRACT 

Environmental 

The environmental fate and effects of the test substance were estimated by using the EPI Suite, 

ECOSAR, E-FAST, and PBT Profiler computer programs. The ECOSAR program predicted the 

48-hour EC50 value for daphnids, the 96-hour LC50 value for fish, and the 72-hour ECso value for 

growth of green algae to be greater than the calculated aqueous solubility of the test substance 

(>6.0 mg!L). The PBT Profiler predicted that this material would not be classified as a PBT 

chemical of concern. TheE-FAST computer program predicted that the wastewater treatment 

facility at Kodak Park would not discharge effluent containing the test chemical at concentrations 

greater than the concentration of concern (296 flg/L) for this material during manufacturing 

operations. 

Health 

Due to a lack of a carcinogenic determinant, the OncoLogic® computer program was not run for 

this compound. In addition, the DEREKTM computer program did not identify any structural 

alerts for toxicity. 

Limited data for the test substance and the sodium salt analog also suggest a low potential for 

toxicity. 
CONFIDENTIAL P2-2003-015 

Page 7 of 18 

STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL 

FATE AND EFFECTS 

HAEL No.:( ___ :J 

CASNo.:f 

KANC J 

CIN: ~~-----__ ~) 

INTRODUCTION AND METHODS 

Structure-activity relationships (SARs) were used to predict the environmental fate and aquatic 

toxicity of the test substance. Structures were entered into computer programs using the 

SMll.,ES (Simplified Molecular Input Line Entry System) notation [1]. The Estimation Programs 

Interface (EPI Suite) computer program developed by Syracuse Research Corporation [2] was 

used to compute estimates of the log Kow value and estimates of environmental fate and 

bioconcentration factor for this chemical. The ECOSAR computer program was used to obtain 

estimates for the aquatic toxicity of this chemical [3]. The PBT Profiler computer program [ 4] 

was used to provide an estimate of the persistence and bioaccumulation of the test chemical. 

Carcinogenic potential was not estimated using the expert system OncoLogic® [5] as the 

chemical did not contain any structural alerts for carcincogenicity. Mammalian target organ 

toxicity was evaluated using the DEREKTM computer modeling program [6] and animal toxicity 

testing for the test chemical and the sodium salt analog. 

RESULTS AND CONCLUSIONS 

Environmental 

Persistence (P2) 

The BIOWIN model within EPI Suite [2] computer program predicted a high probability of rapid 

biodegradation, and the Ultimate Survey Model estimated mineralization would occur within the 

timeframe of "weeks-months". The PBT Pro filer predicted that the substance is likely to ex hi bit 

low persistence in water, moderately persistent in soils, and highly persistent in sediments [4]. 

Therefore, the test substance is likely to be persistent in the environmental media to which it is 

expected to partition: water (15%), soil (76%), and sediment (10%). ··· 

Bioconcentration (Bl) 

The KOWWIN model within the EPI Suite computer program estimated the log Kow to be 4.43 

[2]. Using the estimated log Kow of 4.43, the BCFWIN model calculated a bioconcentration 

factor of 70.8 [2]. This BCF value indicates the test substance is unlikely to bioconcentrate in 

aquatic organisms. 
Toxicity (Tl) 

P2-2003-015 

Page 8 of 18 

The ECOSAR program predicted the 48-hour EC50 value for daphnids, the 96-hour LCso value 

for fish, and the 72-hour EC50 value for growth of green algae to be greater than the calculated 

aqueous solubility of the test substance (>6.0 mg!L). According to U.S. EPA assessment criteria, 

the test substance would be classified as being in the "low concern level" category [8]. 

Aquatic Environment Exposure/Risk 

The following values were used as input for theE-FAST program: manufactured at a rate of 300 

kg/batch (4 batches/yr) with 1 kg/batch going to waste, and 52% removal during wastewater 

treatment. TheE-FAST computer program [9] predicted that the wastewater treatment facility at 

Kodak Park would not discharge effluent containing the test chemical at concentrations greater 

than the concentration of concern (6000 )-tg/L) for this material during manufacturing operations. 

Health 

Carcinogenicity and Mammalian Toxicity (Tl) 

Due to a lack of a carcinogenic determinant, the OncoLogic® computer program was not run for 

this compound [5]. 

Based on animal toxicity testing, this chemical is not acutely toxic by the oral route. No other 

data are available for the test chemical. The sodium salt analog (CAS# 137-20-2) was not 

acutely toxic by the oral or dermal routes. Irritancy was consistent with that observed for other 

anionic surfactants. A reduction in platelet count was observed in a 2-week gavage study in three 

rats; however, clotting time was not affected [7]. 

The DEREKTM computer program [6] was also used to predict the potential toxicological hazards 

of the test substance (Appendix 5). This analysis revealed no structural alerts for toxicity. 

Limited data for the test substance and the sodium salt analog also suggest a low potential for 

toxicity. 

Site-Specific Human Exposure from Drinking Water and Fish Consumption 

Based on estimated release of test substance to the Genesee River from manufacturing operations 

in Rochester, New York, human intake from drinking water was calculated to be 1.15 X 10"8 

mg/kg/day [9]. Similarly, human intake from fish consumption was estimated to be 3.49 x 10-9 

mg/kg/day [9]. Given such low estimated human exposure levels, no human health hazard is 

anticipated due to release of this material to the environment from manufacturing operations. 

35 
REFERENCES 

P2-2003-0 15 

Page 9 of 18 

1. Weininger, A. 1988. "SMll__ES, a Chemical Language and Information System. 1. 

Introduction to Methodology and Encoding Rules." J. Chern. Inf. Comput. Sci. 28:31-36. 

2. Meylan, W. 1993. User's Guide for the Estimation Programs Interface (EPI), Version 

1.2, Syracuse Research Corporation, Syracuse, NY 13210. 

3. Nabholz, J.V. and Cash, G. 1998. ECOSAR Class Program, MS-Windows Version 0.99, 

United States Environmental Protection Agency, Health and Environmental Review 

Division, Environmental Effects Branch, Washington, DC. 

4. PBT Profiler, "U.S. EPA- OPPT, A Component of OPPT's P2 Framework", Version 

1.203; www.pbtprofiler.net. 

5. Woo, Y-T., Lai, D.Y., Argus, M.F., and Arcos, J.C. 1995. "Development of StructureActivity Relationship Rules for Predicting Carcinogenic Potential of Chemicals", 

Toxicol. Lett. 79:219-228. 

6. Greene, N., Judson, P.N., Langowski, J.J., Marchant, C.A. 1999. "Knowledge-Based 

Expert Systems for Toxicity and Metabolism Prediction: DEREK," SAR QSAR Environ. 

Res. 10:299-314. 

7. Eastman Kodak Company. 1985. Unpublished data submitted to EPA underTSCA 

Section 8(d). 

8. Srnrchek, J., Clements, R., Morcock, R., and Rabert, W. 1993. "Assessing Ecological 

Hazard Under TSCA: Methods and Evaluation of Data," Environmental Toxicology and 

Risk Assessment, ASTM STP 1179, W. Landis, J.S. Hughes, and M.A. Lewis, Eds., 

American Society for Testing and Materials, Philadelphia, pp. 22-39. 

9. Brennan, T., U.S. EPA- OPPT, "E-FAST- Exposure and Fate Assessment Screening 

Tool", beta version, www.epa.gov/opptintr/exposure. 
P2-2003-015 

Page 10 of 18 

Appendix 1. Output from the EPI Computer Program [2] 

SMILES :[ 

CHEM : J fONF1DENTIAL 

MOL FOR: j MOL WT : -::;4:r0i'i3:-.c6'""~3,-------...J 

EPI SUMMARY (v3.11) 

Physical Property Inputs: 

Water Solubility (mg/L): 

Vapor Pressure (mm Hg) 

Henry LC (atm-m3/mole) 

Log Kow (octanol-water): 

Boiling Point (deg C) 

Melting Point (deg C) 

Log Octanol-Water Partition Coef (SRC): 

Log Kow (KOWWIN v1.67 estimate) = 4.43 

Boiling Pt, Melting Pt, 

Boiling Pt (deg C) : 

Melting Pt (deg C): 

Vapor Pressure Estimations (MPBPWIN v1.41): 

539.51 (Adapted Stein & Brown method) 

231.05 (Mean or Weighted MP) 

VP(mm Hg,25 deg C): 6.92E-014 (Modified Grain method) 

Water Solubility Estimate from Log Kow (WSKOW vl.41): 

Water Solubility at 25 deg C (mg/L): 0.4748 

log Kow used: 4.43 (estimated) 

no-melting pt equation used 

Water Sol Estimate from Fragments: 

Wat Sol (v1.01 est) = 28.996 mg/L 

ECOSAR Class Program (ECOSAR v0.99g): 

Class~es) found: 

Neutral Organics-acid 

Henrys Law Constant (25 deg C) [HENRYWIN v3.10]: 

Bond Method : 1.00E-012 atm-m3/mole 

Group Method: Incomplete 

Henrys LC [VP/WSol estimate using EPI values]: 7.740E-014 atm-m3/mole 

Probability of Rapid Biodegradation (BIOWIN v4.01): 

Linear Model 0.9823 

Non-Linear Model 0.9998 

Expert Survey Biodegradation Results: 

Ultimate Survey Model: 2.7439 (weeks-months) 

Primary Survey Model : 3.9170 (days } 

Readily Biodegradable Probability (MITI Model): 

Linear Model 0.4418 

Non-Linear Model 0.2188 

Atmospheric Oxidation (25 deg C) [AopWin v1. 91] : 

Hydroxyl Radicals Reaction: 

OVERALL OH Rate Constant 

OVERALL OH Rate Constant 

Half-Life = 1.288 Hrs 

Half-Life= 1.197 Hrs 

Ozone Reaction: 

99.6298 E-12 cm3/molecule-sec [Cis-isome~· 

107.2298 E-12 cm3/molecule-sec [Trans-isomer] 

(12-hr day; 1.5E6 OH/cm3} [Cis-isomer] 

(12-hr day; 1.5E6 OH/cm3} [Trans-isomer] 

OVERALL Ozone Rate Constant 

OVERALL Ozone Rate Constant 

13.000000 E-17 cm3/molecule-sec [Cis-] 

20.000000 E-17 cm3/molecule-sec [TransHalf-Life = 2.116 Hrs (at 7E11 mol/cm3) [Cis-isomer] 

Half-Life = 1. 375 Hrs (at 7Ell mol/cm3) [Trans-isomer] 

Reaction With Nitrate Radicals May Be Important! 

Soil Adsorption Coefficient (PCKOCWIN v1.66}: 

Koc 2.538E+004 

Log Koc: 4.404 2)~ 
P2-2003-015 

Page 11 of 18 

Aqueous Base/Acid-Catalyzed Hydrolysis (25 deg C) [HYDROWIN v1.67]: 

Rate constants can NOT be estimated for this structure! 

BCF Estimate from Log Kow (BCFWIN v2.15): 

Log BCF = 1.850 (BCF = 70.79) 

log Kow used: 4.43 (estimated) 

Volatilization from Water: 

Henry LC: 1E-012 atm-m3/mole (estimated by Bond SAR Method) 

Half-Life from Model River: 1.176E+009 hours (4.901E+007 days) 

Half-Life from Model Lake : 1.283E+010 hours (5.347E+008 days) 

Removal In Wastewater Treatment (recommended maximum 99%) : 

Total removal: 52.30 percent 

Total biodegradation: 0.49 percent 

Total sludge adsorption: 51.80 percent 

Total to Air: 0.00 percent 

Level III Fugacity Model: 

Mass Amount Half-Life Emissions 

(percent) (hr) (kg/hr) 

Air 0.0715 1.16 1000 

Water 25.7 900 1000 

Soil 65.1 900 1000 

Sediment 9.15 3.6e+003 0 

Persistence Time: 710 hr 

· .. 
CONFIDENTIAL 

Appendix 2. Output from the ECOSAR Computer Program [3] 

SMILES :I~ J 

CHEM : L - CAS Num: ----------------------------------------~ 

ChemiD1: 

ChemiD2: 

ChemiD3: 

MOL FOR:( 

MOL WT : 4(T3. 63 

Log Kow: 4.43 (User entered) 

Melt Pt: 

Wat Sol: 5.962 mg/L (calculated) 

ECOSAR v0.99g Class(es) Found 

Neutral Organics-acid 

ECOSAR Class Organism Duration End Pt 

Neutral Organic SAR 

(Baseline Toxicity) 

Fish 14-day LC50 

--> Acid moeity found: Predicted values multiplied by 10 

Neutral Organics-acid Fish 96-hr LC50 

Neutral Organics-acid Fish 14-day LC50 

Neutral Organics-acid Daphnid 48-hr LC50 

Neutral Organics-acid Green Algae 96-hr EC50 

Neutral Organics-acid Fish 30-day ChV 

Neutral Organics-acid Daphnid 16-day EC50 

Neutral Organics-acid Green Algae 96-hr ChV 

Neutral Organics-acid Fish (SW) 96-hr LC50 

Neutral Organics-acid Mysid Shrimp 96-hr LC50 

Neutral Organics-acid : Earthworm 14-day LC50 

Note: * = asterick designates: Chemical may not be soluble 

enough to measure this predicted effect. 

Fish and daphnid acute toxicity log Kow cutoff: 5.0 

Green algal EC50 toxicity log Kow cutoff: 6.4 

Chronic toxicity log Kow cutoff: 8.0 

MW cutoff: 1000 

P2-2003-015 

Page 12 of 18 

Predicted 

mg/L (ppm) 

4.144 

15.552 * 

41.443 * 

19.710 * 

14.172 * 

2.964 

2 0 927 

50 772 

11.537 * 

0.792 

mg/kg (ppm) 

dry wt soil ----------- -----------

4431.375 * 

· .. 
Appendix 3. Output from theE-FAST Computer Program [91 

II ENVIRONMENTAL RELEASES 

Scenario#: 1 Number of Release Sites: 1. 

Release Activity: Manufacture 

Release Description: WATER LANDFILL INCINER LANDIINCIN 

lfotal Releases: 4.00 0.00 0.00 0.00 

(kg/yr) (kg/yr) (kg/yr) (kg/yr) 

Release Days/yr: 4. 

IPer Site Release: 1.00 0.00 0.00 0.00 

(kg/day) (kg/yr) (kg/yr) (kg/yr) 

P2-2003-015 

Page 13 of 18 

FUGITIVE 

0.00 

(kg/yr) 

0. 

0.00 

(kg/day) 
P2-2003-015 

Page 14 of 18 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO#: 1 RELEASE ACTIVITY: 

Manufacture 

FACILITY NAME: EASTMAN KODAK COMPANY 

FACILITY LOCATION: ROCHESTER NY 14652 

RECEIVING WATER NAME: GENESEE RIVER 

REACH NUMBER: 04130003001 FACILITY ON REACH: No DICHARGE TYPE: Indirect 

NPDES PERMIT #: NYOOO 1643 DATA SOURCE: FacSrch EXPOSED POPULATION: Adult 

WWTREMOVAL RELEASE PRE-TREAT POST-TREAT BCF 

(%) DAYS RELEASE (kg/day) RELEASE (kg/day) (L/kg) 

52. 4. 1. 0.48 70.80 

AQUATIC EXPOSURE ESTIMATES- SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 lQlO PLANT 

FLOW(MLD) 3565.86 1528.48 1054.22 851.76 NA 

CONCENTRATION (Jlg/L) 0.13 0.31 0.46 0.56 NA 

41 
DRINKING WATER INGESTION EXPOSURE ESTIMATES 

ASSUMPTIONS 

Exposure Units Results 

ED AT BW 

(years) (years) (kg) 

Cancer 

LADDro, (mg/kg/day) 1.15E-08 30.00 75.00 71.80 

LADCro, (mg/L) 5.90E-07 30.00 75.00 NA 

Chronic Non-Cancer 

ADDro, (mg/kg/day) N/A 30.00 30.00 71.80 

ADCpo, (mg!L) N/A 30.00 30.00 NA 

Acute 

ADRpo, (mg/kg/day) N/A 1.00 day 1.00 day 71.80 

FISH INGESTION EXPOSURE ESTIMATES 

ASSUMPTIONS 

Exposure Units Results 

ED AT BW 

(years) (years) (kg) 

Cancer 

LADDpo, (mg/kg/day) 3.49E-09 30.00 75.00 71.80 

LADCpo, (mg/kg) 4.18E-05 30.00 75.00 NA 

Chronic Non-Cancer 

ADDpo, (mg/kg/day) N/A 30.00 30.00 71.80 

ADCpo, (mglkg) . N/A 30.00 30.00 NA 

Acute 

ADRpo, (mg/kg/day) .N/A 1.00 day 1.00 day 71.80 

P2-2003-015 

Page 15 of 18 

IR 

(L/day) 

1.40 

NA 

1.40 

NA 

6.00 

IR 

(g/day) 

6.00 

NA 

.• < 

6.00 

NA 

129.00 
I 

P2-2003-015 

Page 16 of 18 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO#: 1 RELEASE ACTIVITY: 

FACILITY NAME: EASTMAN KODAK COMPANY 

FACILITY LOCATION: ROCHESTER NY 14652 

RECEIVING STREAM NAME: GENESEE RIVER 

REACH NUMBER: 04130003001 

NPDES PERMIT#: NY0001643 

PERIOD OF RECORD:N/A 

50%ILE FLOW: 6914.60 

coc ()lg/L) % yr exceeded 

6000.00 0.00 

FACILITY ON REACH: Yes 

DATA SOURCE: FacSrch 

#OBSERVATIONS: N/A 

10%ILE FLOW: 1054.22 

RESULTS 

Days/yr Release 

exceeded days/year 

0.00 4.00 

DISCHARGE TYPE: Direct 

STATION ID: N/A 

#STATIONS ON REACH: 

N/A 

EFFLUENT FLOW:126.89 

Loading Waste Water 

(kg/site/day) Treatment (%) 

1.00 52.00 

I 
fONFIDENTIAL 

Appendix 4. Output from the PBT Profiler [4] 

P2-2003-015 

Page 17 of 18 

t"1ethodolo,gy · Criteria · Definitions · Chemicals That Should Not be Profiled _ - -- ·-·-·-·------·-·--··-------------·----··-·-------·-- ··-··--·-----· ---- --· --· ----···-·-···-··-·--·-····-·-·--··-----·--·-····-···-··--···----- : "' 

Home Star1: a [',Jew Profile F<esults Terms of Use Secur-it'y i;O 

Results 

Italicized or underlined highlights indicate that the EPA criteria have been exceeded. 

Color version 

Persistence Bioaccumulation Toxicity 

Media 

Water 

Soil 

Sediment 

Air 

Half-Life 

(days) 

38 

75 

340 

0.058 

c 

PBT Profiler Estimate = P b t 

- 15% 

Percent in 

Each Medium 

---•76% 

• 10% 

0% 

P2 Considerations and more information 

* The predicted water solubility, 0.47 mg/1, is less than the 

estimated Ch V, 3 mg/l. There may be no effect at saturation. 

The PBT Profiler Results are available for 20 minutes 

BCF 

71 

Fish 

ChV 

(mg/l) 

3* 

Developed by the Environmental Science Center under contract to the Office of Pollution 

Prevention and Taxies, U.S. Environmental Protection Agency 

Computer Resources Donated by Syracuse Research Corporation Ver 1.203 Last Updated May 20, 2003 

41 
Appendix 5. Output from the DEREKTM Computer Program [6] 

H\KAN75556 l_DEREKrtf 

DEREK for Windows report 

L116025 

Date Created: Wednesday, October 08, 2003 

Version: 6.0.0 

Database: H:\Dfw6.mdb 

Database Version: DFW6.0.0_2002_07 _18 

User Name: Lll6025 

Testing Against: All Alerts 

Species: mammal 

SuperEndpoints: Carcinogenicity 

Irritation 

Miscellaneous endpoints 

Mutagenicity 

Respiratory sensitisation 

Skin sensitisation 

Thyroid toxicity 

Consider Tautomers: On 

Log Kp: -2.786 Calculated by the Potts & Guy equation 

Log P: 3.702 Calculated by the Moriguchi estimation 

Molecular Weight: 441.712 Calculated by LPS 

Compound Name(____ _ 

Submitted Compound: 

List of alerts found: 

Nothing to report 

P2-2003-015 

Page 18 of 18 

CONFIDENTIAl 

·-. 
FIN/{L REPORT 

( __ 0) 

HAELNo.:( 

CAS No.: Not Available 

ES-98-050 

Page 1 of 14 

CONFIDENTIAL 

KAN:CJ 

CIN: - . _ 

ACTIVATED SLUDGE RESPIRATION INHIBITION SCREENING TEST 

AUTHOR 

Janice M. Beglinger, B.S. 

TESTING FACILITY 

Environmental Sciences Section 

Health and Environment Laboratories 

Eastman Kodak Company 

Rochester, New York 14652-6278 

USA 

STUDY SPONSOR 

Eastman Kodak Company 

STUDY COMPLETION DATE 

July 16, 1998 
ES-98-050 

Page 2 of 14 

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This page has intentionally been left incomplete. 

17 
SIGNATURE PAGE 

ES-98-050 

Page 3 of 14 

ACTIVATED SLUDGE RESPIRATION INHIBITION SCREENING TEST 

Principal Investigator/Report Author 

Unit Director, Environmental Sciences Section 

18 

Month/Day/Year 

J~.JJ '',19>o 

Month/Day/Year 
TABLE OF CONTENTS 

ABSTRACT 

STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

Sponsor 

Study Dates 

Project Participants 

Test Substance Characterization 

Composition and Stability Determination 

Positive Control 

PURPOSE 

MATERIALS AND METHODS 

Test System 

Experimental Design 

Analytical Measurements 

Data Storage 

Data Evaluation and Interpretation 

Calculations 

Test Validity 

RESULTS 

DISCUSSION 

CONCLUSION 

REFERENCES 

TABLE 

ES-98-050 

Page 4 of 14 

Page 

Number 

5 

6 

6 

6 

6 

6 

6 

6 

7 

7 

7 

7 

7 

8 

8 

8 

9 

9 

9 

10 

10 

11 

Table 1. Preparation of Synthetic Feed and Positive Control Solutions 12 

Table 2. Dissolved Oxygen Worksheet for Test Substance 13 

Table 3. Dissolved Oxygen Worksheet for Positive Control 14 
. HAEL No.:(_;;.- J 

CAS No.: Not Available 

CONFIDENTIAL 

c __ ) 

ES-98-050 

Page 5 of 14 

KANo· CIN: _ 

ACTIVATED SLUDGE RESPIRATION INHIBITION SCREENING TEST 

ABSTRACT 

A 3-hour activated sludge respiration inhibition screening test was performed using activated 

sludge from an industrial waste water treatment plant. The sludge microorganisms were exposed 

to replicates of the test substance at one concentration, nominally 1 000 mg/L. Aeration of the 

test solution resulted in foaming, which lasted throughout the test period. Foaming of the test 

solution when aerated, may be a significant effect depending upon the use of the test substance. 

Foaming may also be a concern for waste water treatment as such facilities are aerated. The 

respiration rate, expressed as oxygen consumption by the microbes in mg 02 per liter per hour, 

was measured under defined conditions following the 3-hour exposure period. Inhibition values 

were calculated by comparing test respiration rates to negative control rates. The only 

concentration tested, 1000 mg/L, resulted in 26.6% and 27.5% inhibition. Therefore, the EC50 is 

> 1000 mg/L. A no-observed-effect concentration (NOEC) could not be obtained for this test. 

50 
ES-98-050 

Page 6 of 14 

STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

Environmental Sciences Section 

Health and Environment Laboratories 

Eastman Kodak Company 

Rochester, New York 14652-6278 

USA 

Sponsor 

Eastman Kodak Company 

Study Dates 

Sludge Collection Date: 

Experimental Start Date: 

Experimental Termination Date: 

Project Participants 

Biodegradation Coordinator: 

June 9, 1998 

June 10, 1998 

June 10, 1998 

Principal Investigator/Report Author: 

Test Substance Characterization 

Test Substance Name: 

HAELNo.: 

KAN: 0 

CAS No.: Not Available 

CIN: 

SRID or Lot No.: 

Physical State and Appearance: [ White solid ' 

fONFIDENTIAL 

Charles J. Ruffing, Ph.D. 

.nillice M. Beglinger, B.S. 

Solubility: Not available at test time 

Composition and Stability Determination 

Composition: The composition of this substance was not verified for this screening assay. 

Stability Determination: As part of this test, the test substance is exposed to activated sludge, 

which may degrade the test substance. This study is designed to measure effects of the test 

substance and/or any decomposition products. 

'51 
Positive Control 

Identity: 

CAS Reg. No.: 

Purity: 

3,5-dichlorophenol 

591-35-5 

99.2% 

PURPOSE 

ES-98-050 

Page 7 of 14 

The purpose of this screen is to identify substances that may have adverse effects on aerobic 

sludge microorganisms from waste water treatment plants. The method described assesses the 

effect of a test substance on microbial respiration. The respiration rate, expressed as oxygen 

consumption by the microbes in mg 02 per liter per hour, is measured under defined conditions 

in the presence of the test substance. The data may be used to estimate the potential for 

microbial inhibition at the exposure concentration. 

MA TERJALS AND METHODS 

Test System 

Activated sludge microorganisms were collected from an industrial waste water treatment plant. 

Viability of the microorganisms was confirmed on receipt in the laboratory and activity checked 

by means of a positive control. In studies of this sort no attempt is made to identifY the large 

variety of organisms present in the samples or the degree of absorption of the test and control 

substances. 

Experimental Design 

Preparation of the Inoculum 

On return to the laboratory, the sludge was aerated and stirred at 20 ± 2°C. A small amount 

of the fresh sludge was weighed, oven-dried, and reweighed to determine the oven-dried 

MLSS determination of the fresh sludge in g/L. The sludge was used, as is, the day it was 

received. The pH of the sludge was 7.4 77. After the initial test, it was aerated and fed 

~30 mL each of the Organic Stock and the Phosphate Stock solutions. The sludge was then 

used the following day to repeat the test substance portion of the study. 

Preparation of Test Solutions 

1. Synthetic Feed Stock Solutions: see Table 1. 

2. Positive Control Stock Solution: 3,5-dichlorophenol, a known inhibitor of microbial 

respiration, was used as the positive control (Table 1 ). 

3. Test Substance: the test substance was added directly to the test beakers. 
Experimental Design, continued 

Test Procedure 

ES-98-050 

Page 8 of 14 

In typical respiration inhibition studies, 1-liter beakers are used as the test vessels. At time 

"0", 8 mL of each synthetic feed stock solution was placed in a 200 mL volumetric flask and 

brought to volume with distilled water. Next, 100 mL of distilled water was added to the 

beaker, and then, 200 mL of sludge was added to give a final volume of 500 mL. This 

mixture was placed in the Negative Control beaker. A 5 mL sample was removed from the 

first Negative Control to determine the final sludge concentration in the test beakers. 

Aeration at ~0.8 Llmin was started using a pipet as an aeration device. Test solutions were 

set at 12 minute intervals. 

At time "12 min" (12 minutes is an arbitrary, but convenient, interval) the above was 

repeated for the second beaker containing the limit dose of the test substance. The test 

substance was added directly to the test solution. The theoretical concentration of the test 

substance was 1000 mg/L. The third test vessel was a replicate of the 1000 mg/L. Test 

substance solutions were tested in 2-liter beakers to contain any foam produced. 

Finally, a second Negative Control was prepared. Oxygen consumption was measured and 

recorded after an aeration time of three hours at 22°C. 

On the previous day, the positive control was tested on the microbial inoculum in the same 

way, except that 100 mL of the positive control stock solution were placed in the beakers 

instead of distilled water. The process was repeated at 12-minute intervals to give a series of 

theoretical concentrations of the positive control in the test vessels of 31.25, 9. 77, and 

3.05 mg/L. 

Analytical Measurements 

DO Measurements 

After three hours, a standard BOD measuring bottle was filled from the contents of the first 

beaker and the respiration rate was measured over a period of approximately 9 minutes using 

a dissolved oxygen meter hooked up to a recording chart. This determination was repeated 

on the contents of each vessel at 12-minute intervals so that the exposure time in each beaker 

was three hours. 

Data Storage 

All raw data and summaries of data will be retained for at least ten years in the testing facility 

archive managed under GLP-mandated conditions. 

53 
Data Evaluation and Interpretation 

ES-98-050 

Page 9 ofl4 

Lotus 1-2-3 was used for data calculations. No attempt was made to determine potential 

adsorption of the test substance to the sludge or potential biodegradation of the chemical by the 

microorganisms. The ECso value (if calculated) should be regarded merely as a guide to the 

likely toxicity of the test substance to activated sludge during waste water treatment and to 

microorganisms during biodegradability testing. The complex interactions occurring in the 

environment may not be accurately simulated in a laboratory test. 

Calculations 

The respiration rate was calculated from the recorder trace as mg 02 per liter per hour between 

approximately 6.5 mg 02/L and 2.5 mg 02/L, or over a 9-minute period when the respiration 

rate is low. The respiration rate was measured where the curve was approximately linear. In 

order to calculate the inhibitory effect of a test substance at a particular concentration, the 

respiration rate is expressed as a percentage of the mean of the two control respiration rates: 

(1 - 2RS--) x I 00 = % inhibition 

Rcl + Rc2 

where: 

Rs =oxygen-consumption rate at tested concentration of test substance 

Rc 1 = oxygen-consumption rate, Control 1 

Rc2 =oxygen-consumption rate, Control 2 

The percent inhibition was calculated at each test concentration as above, plotted against 

concentration, and an ECso value derived together with a NOEC. Regression analysis may 

prove useful, and 95% confidence limits for the ECso values can be determined using standard 

procedures. In view of the variability often observed in the results, these may be expressed, if 

desired, in orders of magnitude (i.e., less than 1, 1 to 10, 10 to 100, etc., in mg/L). 

Test Validity 

The two negative control respiration rates were within 15% of each other and the 3-hour ECso 

value of 3 ,5-dichlorophenol was in the range 5 - 30 mg!L. These results meet the criteria for a 

valid test. 

RESULTS 

The final sludge concentration in the test beakers of the initial test was 2.2 giL. Valid results for 

the test substance were not available from the first study. Excessive foaming of the test solution 

when aerated resulted in turning the aeration off. Stirring did not allow for sufficient aeration of 

the test substance solution. The positive control concentrations were not affected and the results 

were used. The positive controls (concentration 31.25, 9.77, and 3.05 mg/L of 3,5-

dichlorophenol) had respiration rates of 17.14, 34.29, and 38.77 mg 02L-l hr-1, respectively, 
ES-98-050 

Page 10 ofl4 

resulting in an ECso value of26.9 mg/L as calculated by regression analysis. Respiration rates 

for the two negative controls were 41.60 and 40.50 mg 02L -1 hr-1, respectively, resulting in a 

mean value of41.1 mg 02L-1hr-1. 

The final sludge concentration of the second test was 2.3 g/L. The respiration rates for the 

1000 mg/L replicates, were 30.40 and 30.00 mg 02L-1hr-1, respectively, resulting in inhibition 

values of26.6% and 27.5%. Respiration rates for the first and last negative controls were 42.00 

and 40.80 mg 02L -1 hr-1, respectively, resulting in a mean value of 41.4 mg 02 L -1 hr-1. 

DISCUSSION 

This screening study was conducted based on the respiration inhibition test described in OECD 

Guideline 209. The actual values obtained during the experiment are reported here, together with 

the warning that the result variability, as stated in the OECD Guideline, may indeed be 

unavoidable in this test. 

Two tests were conducted for this test substance. The first test resulted in significant foaming 

when the test substance was aerated. To stop the foaming, aeration to the test substance beaker 

was discontinued, while stirring was increased. Stirring did not cause foaming, but a useable 

reading for the test substance was not achieved. As two Negative Controls and the Positive 

Controls were not affected, the ECso for the Positive Control was used for the study. The 

remaining sludge was fed and aerated overnight. That sludge was then used to repeat the test for 

the test substance, in replicates, and two Negative Coflfrols. The test substance solution was put 

into 2-L beakers to contain the foam. Foaming of the test substance, which filled the beakers, 

was observed throughout the 3-hour test period. 

The only concentration tested, 1000 mg/L (nominal), resulted in 26.6% and 27.5% inhibition. 

Therefore, the ECso is> 1000 mg/L. The ECso value should be regarded merely as a guide to 

the likely toxicity of the test substance to either activated sludge sewage treatment or to waste 

water treatment microorganisms, since the complex interactions occurring in the environment 

cannot be accurately simulated in a laboratory test. A no-observed-effect concentration (NOEC) 

could not be obtained for this test as an effect was observed at the single concentration tested. 

While some inhibition resulted at 1000 mg/L, the foaming of the test solution when aerated, may 

be a significant effect depending upon the use of the test substance. Foaming may also be a 

concern for waste water treatment as such facilities are aerated. 

CONCLUSION 

While some inhibition (26.6% & 27.5%) resulted at 1000 mg/L, the foaming of the test solution 

when aerated, may be a significant effect depending upon the use of the test substance. Foaming 

may also be a concern for waste water treatment as such facilities are aerated. A no-observedeffect concentration (NOEC) could not be obtained for this test. The ECso is > 1 000 mg/L. 

55 
REFERENCES 

ES-98-050 

Page 11 of 14 

1. Annex V Supplement, L 133, Official Journal of the European Communities 11_, 118 (1988). 

2. OECD Guidelines for Testing of Chemicals, 1992. Activated Sludge, Respiration Inhibition 

Test Guideline 209. Effects on Biotic Systems. 

3. ETAD (Ecological and Toxicological Association ofDyestuffs Manufacturing Industries) 

Recommended Method No. 103. 
J 

ES-98-050 

Page 12 of 14 

TABLE 1. Preparations of Synthetic Feed and Positive Control Solutions 

I. Synthetic Feed Stock Solutions 

A. Organic Stock Solution 

Peptone 

Beef Extract 

Urea 

Sodium Chloride (NaCI) 

Calcium Chloride Dihydrate (CaCl2•2H20) 

Magnesium Sulfate Heptahydrate (MgS04•7H20) 

Dissolve in 500 mL of distilled water. 

B. Phosphate Stock Solution 

Dipotassium Hydrogen Phosphate (K2HP04) 

Dissolve in 500 mL of distilled water. 

Amount 

16.0 g 

11.0 g 

3.0 g 

0.7 g 

0.4 g 

0.2 g 

2.8 g 

Note: This synthetic feed is a 200-fold concentrate of that described in the OECD 

Technical Report "Proposed Method for the Determination of the Biodegradability of 

Surfactants used in Synthetic Detergents" June 11, 1976, with more dipotassium 

hydrogen phosphate added. This concentrate must be prepared in two separate stock 

solutions to prevent precipitation. 

II. Positive Control Stock Solution 

The solution of 3,5-dichlorophenol is prepared as follows: 

1. Dissolve 0.5 g of3,5-dichlorophenol in 10 mL of IN NaOH. 

2. Dilute to approximately 30 mL with distilled water. 

3. Add, while stirring, IN H2S04 to the point of incipient precipitation- approximately 

8 mL of 1 N H2S04 will be required. 

4. Finally, dilute the mixture to one liter with distilled water. The pH should then be in the 

range 7 to 8. Adjust with IN H2S04 if necessary. 

51 
fONFIDENTIAL 

TABLE 2. Dissolved Oxygen Worksheet for Test Substance 

ES-98-050 

Page 13 of 14 

c- ~ 

DISSOLVED OXYGEN WORKSHEET 

~ 

TEST: Respiration lnhib. Screen 

BEAKERS CONC. UPPER LOWER DIST. 

(mg/L) VALUE VALUE (tm) 

(A) (A) 

#1 NEG. CONT. 0 5.2 3.1 12.0 

#2 TEST A 1000.00 5.1 3.2 15.0 

#3 TEST B 1000.00 5.7 4.2 12.0 

TEST X XXX XXX XXX 

TEST X XXX XXX XXX 

TEST X XXX XXX XXX 

POS. CONT. 31.25 XXX XXX XXX 

POS. CONT. 9.n XXX XXX XXX 

POS. CONT. 3.05 XXX XXX XXX 

#4 NEG. CONT. 0 4.7 3.0 10.0 

(A) = mg of oxygen from Dissolved Oxygen Meter's recorder trace 

(B) = Respiration rate in mg of oxygen per liter per hour 

CHART 

SPEED 

(em/min) 

4 

4 

4 

4 

4 

4 

4 

4 

4 

4 

Note: The Negative Controls should be within 15% = ~.e., MEAN +/- 7.5%) 

41.4 +/-

Remarks: Only one concentration tested, in replicate, at 1000 mgll. 

Repeat for the test article, due to previous test failure. Positive Control values from the first test were used. 

Test article was aerated, foaming continued throughout the test period. 

Actual Final Sludge concentration in test beakers was 2.3 giL (aim 1.6 giL). 

5S 

RESP. IN HI B. 

RATE 

(B) 

42.00 

30.40 26.6% 

30.00 27.5% 

ERR ERR 

ERR ERR 

ERR ERR 

ERR ERR 

ERR ERR 

ERR ERR 

40.80 

3.1 
fONFIDENTIAL 

TABLE 3. Dissolved Oxygen Worksheet for Positive Control 

ES-98-050 

Page 14 of 14 

GEL No. 98-0024~ c 

--~ DISSOLVED OXYGEN WORKSHEET 

TEST: Respiration lnhib. Screen 

BEAKERS 

#1 NEG. CONT. 

#2 TEST 

TEST 

TEST 

TEST 

TEST 

#4 POS. CONT. 

#5 POS. CONT. 

#6 POS. CONT. 

#3 NEG. CONT. 

X 

X 

X 

X 

CONC. 

(mg/L) 

0 

1000.00 

31.25 

9.77 

3.05 

0 

UPPER LOWER 

VALUE VALUE 

(A) (A) 

5.1 2.5 

See Remarl<s 

XXX XXX 

XXX XXX 

XXX XXX 

XXX XXX 

6.5 5.5 

6.0 4.0 

4.7 2.6 

5.4 2.7 

(A) = mg of oxygen from Dissolved Oxygen Meter's recorder trace 

(B) = Respiration rate in mg of oxygen per liter per hour 

Note: The Negative Controls should be within 15% = ~.e., MEAN+/- 7.5%) 

DIST. CHAR'f-

(c'm) ~SPEED 

/// (em/min) 

/ 

15.6" 4 

XXX 4 

XXX 4 

XXX 4 

XXX 4 

14.0 4 

14.0 4 

13.0 4 

16.0 4 

41.1 +/-

RESP. 

RATE 

(8) 

41.60 

ERR 

ERR 

ERR 

ERR 

ERR 

17.14 

34.29 

38.77 

40.50 

3.1 

Remarl<s: Due to foaming at test start, the aeration was turned off of the 1000 mg/L. The stir-bar was lef1 on. 

At test end, the reading was not useable. The test was repeated the following day for the test article. 

Actual Final Sludge concentration is test beakers was 2.2 g/L (aim 1.6 g!L). 

IN HI B. 

ERR 

ERR 

ERR 

ERR 

ERR 

58.2% 

16.5% 

5.6% 
TX-98-145 

Page 1 of 15 

FINAL REPORT fONFIDENTIAL 

HAELNo.~ 

CIN:c==J 

KAN: ( I 

RAN:(--) 

ACUTE ORAL TOXICITY STUDY IN THERA T 

GUIDELINE 

OECD: 401 

EEC: Annex V., Test B.1 

AUTHOR 

Kenneth P. Shepard, B.S. 

TESTING FACILITY 

Toxicological ScienceS'Laboratory 

Health and Environment Laboratories 

Eastman Kodak Company 

Rochester, New York 14652-6272 

USA 

LABORATORY PROJECT ID 

STUDY SPONSOR 

Eastman Kodak Company 

STUDY COMPLETION DATE 

August 13, 1998 
TX-98-145 

Page 2 of 15 

fONFIDENTIAL 

QUALITY ASSURANCE INSPECTION STATEMENT 

{21 CFR 58.35{B) (7), 40 CFR 792.35(B) (7), AND 40 CFR 160.35(B) (7)) 

STUDY: r STUDY DIRECTOR: SHEPARD,K.P. PAGE 1 ---" ACCESSION NUMBER: (_____,) 08/11/98 

STUDY TYPE": ACUTE ORAL TOXICIJY 

J1'1" tfci7o 

DATE 

THIS STUDY WAS INSPECTED BY 1 OR MORE PERSONS OF THE QUALITY 

ASSURANCE UNIT. WRITTEN STATUS REPORTS WERE SUBMITTED ON THE 

FOLLOWING DATES. 

INSPECTION 

DATES 

PHASE(S) 

INSPECTED 

06/10/98 PROTOCOL APPENDIX/AMENDMENT S~MISSION 

06/11/98 CLINICAL SIGNS AT 24 HRS. 

08/11/98 FINAL REPORT REVIEW 

STATUS REPORT 

DATES 

08/11/98 

08/11/98 
TX-98-145 

Page 3 of 15 

GOOD LABORATORY PRACTICE COMPLIANCE STATE.MENT 

This study was conducted according to: 

Annex 2, Organisation for Economic Cooperation and Development, Guidelines 

' for Testing of Chemicals [C(81)30(Final)]. 

~.~~~J Kenneth P. Shepard, B.S. 

Study Director 

Month!Day/Y ear 
SIGNATURE PAGE 

Study Director 

Unit 

Do1t~.D Director, Mammalian Toxicology 

John L. 0' 

TX-98-145 

Page 4 of 15 

Month/Day/Year 

A~ IZ,If98 

Mont&riay/Y ear 

Month/Day/Year 
TABLE OF CONTENTS 

ABSTRACT 

STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

Project Participants 

Sponsor 

Test Substance Characterization 

Study Dates 

PURPOSE 

MATERIALS AND .METHODS 

Test System 

Husbandry 

Experimental Design 

Data Storage 

Statistical Procedures 

Protocol and Standard Operating Procedure Deviations 

RESULTS 

DISCUSSION 

CONCLUSION 

REFERENCES 

APPENDIX 

TX-98-145 

Page 5 of 15 

Page 

Number 

6 

7 

7 

7 

7 

7 

7 

8 

8 

8 

8 

9 

11 

11 

11 

12 

14 

14 

14 

15 
ABSTRACT 

HAELN~~ 

CIN: (_ _> 

TX-98-145 

Page 6 of 15 

CONFIDENTIAL 

KAN:~ 

RAN~ 

ACUTE ORAL TOXICITY STUDY IN THE RAT 

An acute oral toxicity study was conducted with five male and five female rats administered a 

single limit dose of 2000 mg/kg of the test substance by gavage. The test substance was 

administered as a 20% solution using distilled water as the vehicle. A single male was found dead 

on the morning following dosing. No other mortality was noted during the study. The acute oral 

LD50 for this test substance was greater than 2000 mg/kg for male and female rats. 

Abnormal clinical signs noted during the 14-day observation period were limited to diarrhea on 

the day of dosing and fecal staining of the inguinal hair and discolored (light brown) feces on the 

day following administration of the test substance. No other abnormal clinical signs were evident 

during the study. All surviving animals gained weight during both weeks of the study. 

Treatment-related changes observed at necropsy for the single male which died after exposure to 

the test substance were limited to the presence of the test substance in the stomach and 

incomplete collapse of the lungs. No treatment-related changes were noted at necropsy for 

animals which survived to termination of the study. No tissue was collected for microscopic 

examination. 

Based on the results of this study, the test substance was classified as, at most, slightly toxic 

according to the criteria set forth by Hodge and Sterner ( 1949) and requires no toxicity 

classification as defined in the 18th Adaptation of the EC Classification, Packaging, and Labelling 

of Dangerous Substances Directive. 
TX-98-145 

Page 7 of 15 

STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

Toxicological Sciences Laboratory 

Health and Environment Laboratories 

Eastman Kodak Company 

Rochester, New York 14652-6272 

USA 

Project Participants 

Study Director: 

Principal Investigator: 

Report Author: 

Sponsor 

Eastman Kodak Company 

Test Substance Characterization 

Test Substance Name: 

CAS No: 

HAELNo.: 

KAN: 

CIN: 

SRID or Lot No.: 

Physical State and Appearance: 

Source of Test Substance: 

Laboratory Project ID: 

fONFJDENTIAL 

Kenneth P. Shepard, B.S. 

John W. Mosher, B.S. 

Kenneth P. Shepard, B.S. 

(- ) 

Not available 

Solid, Whtte 

Eastman Kodak Company 

<__ ) 

Composition: Refer to composition information included in the notification when applicable. 

Study Dates 

Study Initiation Date: 

Experimental Start Date: 

Experimental Completion Date: 

June 10, 1998 

June 10, 1998 

June 24, 1998 
PURPOSE 

TX-98-145 

Page 8 of 15 

The purpose of the study was to determine the estimated ora] LD50 of the test substance in male 

and female rats and the clinical signs of toxicity associated with a single oral dose. 

MATERIALS AND METHODS 

Test system 

Five male and five female Sprague-Dawley rats (CD®(SD)BR/V AF Plus®) obtained from Charles 

River Kingston (Stone Ridge, NY) were randomly assigned to the study. At initiation of the 

study, male rats were 6-7 weeks of age and weighed 128 to 145 grams and female rats were 7-8 

weeks of age and weighed 140 to 158 grams. Rats were chosen for this study because they are a 

common representative species for toxicity studies. The rat is one of two primary rodent species 

recommended for use in the OECD Guideline. 

Husbandry 

Housing 

Animals were housed in an American Association for Accreditation of Laboratory Animal 

Care-accredited vivarium in accordance with th~ Guide for the Care and Use of 

Laboratory Animals (National Research Council, 1996). The rats were singly housed in 

suspended, stainless-steel, wire mesh cages. Cages and racks were washed once a week. 

Absorbent paper, used to collect excreta, was changed at least three times a week. 

Environmental Conditions 

The study room was maintained at 18.5-23.3 oc and 37.9-79.4% relative humidity, except 

on Day 6 of the study when the animal room was washed and relative humidity transiently 

reached 96.9%. A photoperiod of 12 hours light from 6 a.m. to 6 p.m. was maintained. 

Acclimation Period 

The animals were isolated upon arrival and allowed to acclimate for a period of 5 days. 

Animals were judged to be healthy prior to testing. 
Husbandry, continued 

Feed 

TX-98-145 

Page 9 of 15 

Certified Rodent Diet (PM~ #5002, pelleted) was available ad libitum. Feed containers 

were cleaned weekly and refilled at least once a week. No known contaminants which 

would interfere with the outcome of this study were present in the feed. Analyses of feed 

are maintained on file within the testing laboratory. 

Water was available ad libitum through an automatic watering system. The source of the 

water was the local public water system. There have been no contaminants identified in 

periodic water analyses that would be expected to interfere with the conduct of the study. 

Semiannual analyses of water are maintained on file within the testing laboratory. 

Identification 

Upon arrival, aU rats were identified by uniquely-numbered metal ear tags. During 

randomization, study-specific animal numbers were assigned to each animal. Cage cards 

contained the study-specific animal number and the ear tag number. 

Experimental Design 

Test Procedures 

This study was conducted according to the Organisation for Economic Cooperation and 

Development (OECD) Guidelines for Testing of Chemicals Guideline: 401, Acute Oral 

Toxicity~ and European Economic Community (EEC): Annex V., Test B.l , Acute 

Toxicity (Oral). 

Randomization 

The procedure for including animals in the study was to randomly select and assign 

animals from the same shipment to the study. Randomization was done by computergenerated lists. After assignment of animals to the study, the body weights were 

determined to ensure that variation in individual body weights did not exceed 20% of the 

mean weight for each sex. 

Determination of Dose Levels 

A limit dose of 2000 mg of the test substance/kg body weight was selected as the dose 

level for the oral toxicity study. 
Experimental Design, continued 

Preparation of Test Substance in the Vehicle 

TX-98-145 

Page 10 of 15 

The test substance, a solid, was administered as a 20% solution using distilled water as the 

vehicle. 

Test Substance Exposure 

A single dose of the test substance was administered by gavage to animals that had been 

fasted overnight. 

Distribution of Animals 

TABLE 1 

Animal Distribution 

Dose Level Number Of Animal Numbers 

Animals Males I Females 

2000mg/kg 5 Males & 5 Females 391 - 395 396-400 

Body Weights 

Body weights were collected on Days 0 (prior to treatment), 7, and 14. 

Clinical Observations 

Animals were observed three times on the day of dosing (Day 0), and once each day 

thereafter for the duration of the experiment. Observations included, but were not limited 

to, examination of the hair, skin, eyes, mucous membranes, motor activity, feces, urine, 

respiratory system, circulatory system, autonomic nervous system, central nervous system, 

and behavior patterns. 

Necropsy 

Any animal that died during the study was necropsied as soon as possible. All surviving 

animals were euthanatized and necropsied at the completion of the 14-day observation 

period. 
Data Storage 

TX-98-145 

Page II of 15 

The final report, data sheets, all nonperishable raw data, and an aliquot of the test substance have 

been stored in the testing facility archive managed under GLP-mandated conditions. 

Statistical Procedures 

No statistical procedures were required during the study. No dose/mortality curve was 

constructed since graphs become statistically useful only with the use of large numbers of animals 

and dose groups. 

Protocol and Standard Operating Procedure Deviations 

The were no SOP or protocol deviations during the study. 

70 
Mortality 

RESULTS 

TX-98-145 

Page 12 of 15 

The dose level, the number of animals dosed, and the number and time of deaths are listed in 

Table 2. 

TABLE2 

Mortality Table 

Dose (mglkg) Number of Rats Exposed Number of Deaths 

2000 5 Males, 5 Females I Male 

Time of Death 

Within 24 Hours 

LD50 for male rats: 

LD50 for female rats: 

> 2000 mg/kg (95% C.I. =No Range Calculable) 

> 2000 mg/kg (95% C.l. =No Range Calculable) 

Clinical Signs 

The time of each observation and the number of anim~ involved are listed in Table 3. 

TABLE3 

Table Of Clinical Observations 

Dose Time Clinical Signs Number of Animals 

(mglkg) Affected 

2000 DayO Appeared Clinically Normal 4/5 Males, 3/5 Females 

Diarrhea 115 Males, 215 Females 

2000 Day 1 Found Dead 115 Males 

Discolored (Light Brown) Feces 4/4 Males, 5/5 Females 

Fecal Staining of Inguinal Hair 1/4 Males, 5/5 Females 

2000 Days 2 to 14 Appeared Clinically Normal 4/4 Males, 5/5 Females 

Weight Gain 

All surviving animals gained weight during both weeks of the study. 

11 
Individual Body Weights 

The individual body weights are listed in Table 4. 

TABLE4 

TX-98-145 

Page 13 of 15 

Table Of Individual Body Weights (grams) 

I Dose (mglkg) I Animal Number DayO Day7 Day 14 

MALE RATS 

2000 391 130 207 276 

2000 392 143 222 280 

2000 393 144 223 285 

2000 394 128 200 246 

2000 395 145 Found Dead Day 1 

FEMALE RATS 

- 2000 396 158 211 236 

2000 397 153 204 219 

2000 398 140 184 197 

2000 399 152 209 234 

2000 400 147 203 222 

Necropsy Findings 

No treatment-related changes were observed at necropsy for animals surviving to termination of 

the study. For the single male which died within 24 hours of dosing (Rat 395), changes noted at 

necropsy were limited to the presence of the test substance in the stomach and incomplete 

collapse of the lungs. The incomplete collapse of the lungs when the thoracic cavity was opened 

during necropsy was considered an incidental fmding. In the absence of significant gross organ 

lesions, no tissue was collected for microscopic examination. A detailed record of the tissues 

examined is presented in computer-generated tables which are included in the Appendix. 

1~ 
DISCUSSION 

TX-98-145 

Page 14of15 

This acute oral toxicity study was conducted with five male and five female rats administered a 

single limit dose of 2000 mg/kg of the test substance administered as a 20% solution in distilled 

water. A single male was found dead on the morning following dosing. No other mortality was 

noted during the study. 

Abnormal clinical signs noted during the 14-day observation period were limited to diarrhea on 

the day of dosing and fecal staining of the inguinal hair and discolored (light brown) feces on the 

day following administration of the test substance. No other abnormal clinical signs were evident 

during the study. All surviving animals gained weight during both weeks of the study. 

Treatment-related changes observed at necropsy for the single male which died after exposure to 

the test substance were limited to the presence of the test substance in the stomach and 

incomplete collapse of the lungs. No treatment-related changes were noted at necropsy for 

animals which survived to termination of the study. No tissue was collected for microscopic 

examination. The acute oral LD50 for this test substance was greater than 2000 mg/kg for male 

and female rats. 

CONCLUSION 

Based on the oral LD5o for male and female rats, the test substance was classified as, at most, 

slightly toxic according to the criteria set forth by Hod-ge and Sterner (1949) and requires no 

toxicity classification as defined in the 18th Adaptation of the EC Classification, Packaging, and 

Labelling of Dangerous Substances Directive. 

REFERENCES 

Hodge, H.C. and Sterner, J.H. (1949). Tabulation of toxicity classes. Am. Indust. Hyg. Quart., 

10,93-96. 

National Research Council ( 1996). Guide for the Care and Use of Laboratory Animals. 

National Academy Press. Washington, D.C. 

13 
APPENDIX 

74 

TX-98-145 

Page I 5 of 15 
SUMMARY GROSS PATHOLOGY INCIDENCE TABLE - MALE RATS 

GROUP 

TRACHEA 

LUNGS 

INCOMPLETE COLLAPSE OF THE LUNGS 

THYMUS 

HEART 

ESOPHAGUS 

STOMACH 

TEST SUBSTANCE PRESENT 

DUODENUM 

JEJUNUM 

ILEUM 

CECUM 

COLON 

RECTUM 

LIVER 

KIDNEYS 

URINARY BLADDER 

PITUITARY GLAND 

ADRENALS 

PANCREAS, NOS 

THYROID GLANDS 

PARATHYROID GLANDS 

SPLEEN 

MESENTERIC LYMPH NODES 

BONE MARROW 

BRAIN 

EYES 

SALIVARY GLANDS 

ADIPOSE TISSUE 

SKIN, NOS 

HAIR 

ACCESSORY SEX ORGANS (MALE) 

EPIDIDYMIDES 

TESTES 

2000 MG/KG 

5 

5 

1 

5 

5 

5 

5 

1 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

TX-98-145 

Appendix 

Page l of 4 

NUMBERS REPRESENT NUMBER OF TISSUES EXAMINED, OR IN THE CASE OF ABNORMAL FINDINGS, 

THE NUMBER OF TISSUES WITH EACH ABNORMALITY 
GROUP 

TRACHEA 

LUNGS 

THYMUS 

HEART 

ESOPHAGUS 

STOMACH 

DUODENUM 

JEJUNUM 

ILEUM 

CECUM 

COLON 

RECTUM 

LIVER 

KIDNEYS 

URINARY BLADDER 

PITUITARY GLAND 

ADRENALS 

PANCREAS, NOS 

THYROID GLA.t'IDS 

PARATHYROID GLANDS 

SPLEEN 

SUMMARY GROSS PATHOLOGY INCIDENCE TABLE - FEMALE RATS 

2000 MG/KG 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

MESENTERIC LYMPH NODES 

5 

5 

BONE MARROW 

BRAIN 

EYES 

SALIVARY GLANDS 

ADIPOSE TISSUE 

SKIN, NOS 

HAIR 

FALLOPIAN TUBES 

VAGINA 

UTERUS 

OVARIES 

CERVIX UTERI 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

5 

TX-98-145 

Appendix 

Page 2 of 4 

NUMBERS REPRESENT NUMBER OF TISSUES EXAMINED, OR IN THE CASE OF ABNORMAL FINDINGS, 

THE NUMBER OF TISSUES WITH EACH ABNORMALITY 

70 
TX-98-145 

Appendix 

Page 3 of 4 

INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABLE - MALE RATS 

ANIMAL # 

DAYS ON TEST 

TRACHEA 

LUNGS 

INCOMPLETE COLLAPSE 

THYMUS 

HEART 

ESOPHAGUS 

STOMACH 

TEST SUBSTANCE PRESENT 

DUODENUM 

JEJUNUM 

ILEUM 

CECUM 

COLON 

RECTUM 

LIVER 

KIDNEYS 

lJRINARY BLADDER 

PITUITARY GLAND 

ADRENALS 

PANCREAS, NOS 

THYROID GLANDS 

PARATHYROID GLANDS 

SPLEEN 

MESENTERIC LYMPH NODES 

BONE MARROW 

BRAIN 

EYES 

SALIVARY GLANDS 

ADIPOSE TISSUE 

SKIN, NOS 

HAIR 

ACCESSORY SEX ORGANS (MALE) 

EPIDIDYMIDES 

TESTES 

391 392 393 394 395 

14 14 14 14 1 

X X X X X 

X X X X 

p 

X X X X X 

X X X X X 

X X X X X 

X X X X 

p 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

KEY: N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY, 1-MINIMAL, 2-MINOR, 3-MODERATE, 

4-SEVERE, P-PRESENT, A-ABSENT, *-SEE COMMENT REPORT, X=NORMAL BUT NOT COLLECTED 

77 
TX-98-145 

Appendix 

Page 4 of 4 

) 

INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABLE -FEMALE RATS 

ANIMAL # 

DAYS ON TEST 

TRACHEA 

LUNGS 

THYMUS 

HEART 

ESOPHAGUS 

STOMACH 

DUODENUM 

JEJUNUM 

ILEUM 

CECUM 

COLON 

RECTUM 

LIVER 

KIDNEYS 

URINARY BLADDER 

PITUITARY GLAND 

ADRENALS 

PANCREAS, NOS 

THYROID GLANDS 

PARATHYROID GLANDS 

SPLEEN 

MESENTERIC LYMPH NODES 

BONE MARROW 

BRAIN 

EYES 

SALIVARY GLANDS 

ADIPOSE TISSUE 

SKIN, NOS 

HAIR 

FALLOPIAN TUBES 

VAGINA 

UTERUS 

OVARIES 

CERVIX UTERI 

396 397 398 399 400 

14 14 14 14 14 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X. X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X A X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

X X X X X 

KEY: N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY, 1-MINIMAL, 2-MINOR, 3-MODERATE, 

4-SEVERE, P-PRESENT, A-ABSENT, *-SEE COMMENT REPORT, X=NORMAL BUT NOT COLLECTED 
CONFIDENTIAL 

FINAL REPORT 

PURITY DETERMINATION 

AUTHOR 

Tracey L. Sanford 

TESTING FACILITY 

Environmental Analytical Services 

Chemicals Quality Services Division 

Manufacturing Quality Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652-6276 

USA 

STIJDY SPONSOR 

Eastman Kodak Company 

REPORT No: L8329-PKV 

STIJDY COMPLETION DATE 

July 16, 1998 

79 
• t 

CONFIDENTii\L 

ANALYTICAL QUALITY ASSURANCE INSPECTION STATDU:NT 

(CrR 58.35(8)(7) 792.35(8)(7) 160.35(8)(7)) 

STUDY: STUDY DIRECTOR: ISAAC3,8 

ANALYTICAL DIRECTOR: 

CQS JOB lroMBER: 

STUDY TYPE: 

THE FOLLOWING PRA.SES Of' THIS STUDY WERE INSPECT!.D BY ONE OR MORE PERSONS OF 

THE QUALITY ASSURANCE U}IIT OH THE DATES LISTED BELOW. WRITTEN STATUS REPORTS 

WERE SUBMITTED TO THE STUDY DIRECTOR AND JI.PPROPJ'UA!'l: MI'.NAGEXDIT. 

INSPECT REQUEST PHASE ( S) STATUS REPORT 

DATES HUMBER INSPECTED DATES 

------- ------- --------- ----------- 06/23/98 PROTOCOL SUBMISSION 06/23/98 

CRI, PUR 

06/23/98 PHASE INSPECTION 06/23/98 

CRI, PUR 

07/16/98 TEST REPORT INSPECTIOH 07/16/98 

CRI, PUR 

Page 2 of 19 

8D 

L8329-PKY 

' ) 

) 

) 
! 

' 

GOODLABORATORYPRACTICECO~L~CESTATEMENT 

This study was conducted according to: 

Uruted States Food and Drug Administration, Good Laboratory Practice for Nonclinical 

Laboratory Studjes, 21 CFR Part 58; 

United States Environmental Protection Agency, Toxic Substances Control Act, Good 

Laboratory Practice Standards, 40 CFR Part 792; 

Annex 2, Organization for Economic Cooperation and Development, Guidelines for the 

Testing of Chemicals (C(81)30(Fina1)). 

Beth 

Study 

DP=#~~ Isaacs 

Director 

~ 

Page 3 of 19 

8/ 

~ llo, 1116' 

nth/Day/Year 

L8329-PKY 
Report Author 

Beth 

~~ Isaacs 

Study Director 

SIGNATURE PAGE 

) 

ontb!Day/Y ear 

U Month!Day/Y ear 

L8329-PKV ) 
l 

TABLE OF CONTENTS 

LIST OF FIGURES 

ABSTRACT 

STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

PURPOSE 

Sponsor 

Sponsor Representative 

Study Dates 

Project Participants 

Test Substance Characterization 

Test Substance Storage 

1\t>\. TERIALS AND l\IETHODS 

RESULTS 

Purity Determination Procedure 

Weight Percent Water Detennination Procedure 

Weight Percent Volatiles Determination Procedure 

Weight Percent Methanol and Acetone Determination Procedure 

Instrument Conditions 

Calculations 

Protocol and Standard Operating Procedure Deviations 

Data Storage and Record Retention 

Weight Percent Purity 

Weight Percent Water 

Weight Percent Volatiles 

Weight Percent Methanol and Acetone 

CALCULATIONS 

DISCUSSION 

CONCLUSIONS 

Page 5 of 19 

83 

Page 

6 

7 

8 

8 

8 

8 

8 

9 

9 

9 

9 

9 

9 

10 

10 

10 

10 

11 

12 

12 

12 

12 

12 

12 

13 

13 

14 

14 

L8329-?KV 
) 

LIST OF FIGURES 

I. Titration Curve ofTest Substance 15 

II. Titration Curve ofBlank Solvent 16 

ill. Chromatogram ofBlank Acetonitrile 17 

IV. Chromatogram ofMethanol and Acetone Standard in Acetonitrile 18 

V. Chromatogram of Test Substance in Acetonitrile 19 

Page 6 of 19 L8329-PY:V ) 

J 
CONFIDENTIAL 

c ) 

ABSTRACf 

The purity of the test substance was analyzed in triplicate for weight percent purity using 

potentiometric titration with 0.1 N perchloric acid (HC104). The mean weight percent 

purity was determined to be 99.8 with a standard deviation of0.58. 

The test substance was analyzed in triplicate for weight percent water using an 

A QUAST AR 13 V5000 Karl Fischer titrator. The mean weight percent water was 0.69 with 

a standard deviation of0.018. 

The test substance was analyzed in triplicate for weight percent volatiles using the Denver 

IR-1 00 moisture analyzer. The mean weight percent volatiles at 105 oc was 0.88 with a 

standard deviation of 0. 092. 

The test substance was analyzed for weight percent methanol and acetone using gas 

chromatography with flame ionization detection. No methanol or acetone peaks were 

detected above the instrument detection limit in the test substance .. The weight percent 

methanol and acetone are reported as less than the respective method detection lirrllts of 

0.01 and 0.001 weight percent. The 0.19 weight percent volatiles unaccounted for were not 

identified. 

Page 7 of 19 L8329-PKV 
STUDY AND TEST SUBSTANCE INFO~IATION 

Testing Facility 

Environmental Analytical Services 

Chemicals Quality Services Division 

Eastman Kodak Company 

Rochester, New York 14652-6276 

USA 

Sponsor 

Eastman Kodak Company 

Rochester, New York 14652 

USA 

Sponsor Representative 

Julie Byrne 

Eastman Kodak Company 

Rochester, New York 14652 

USA 

Study Dates 

Study Start Date: 

Purity: 

Experimental Start Date: 

Experimental Completion Date: 

Weight Percent Water: 

Experimental Start Date: 

Experimental Completion Date: 

Weight Percent Volatiles: 

Experimental Start Date: 

Experimental Completion Date: 

June 22, 1998 

June 22, 1998 

June 23, 1998 

July 6, 1998 

July 6, 1998 

July 6, 1998 

July 6, 1998 

Weight Percent Methanol and Acetone: 

Experimental Start Date: July 9, 1998 

Experimental Completion Date: July 10, 1998 

Page 8 of 19 

) 
( 

Project Participants 

Study Director: 

Principal Investigators: 

Report Author: 

Test Substance Characterization 

Received into Laboratory 

Test Substance Storage 

CONFIDENTIAL 

Beth Isaacs 

Tracey Sanford 

Beth Isaacs 

Gina Lynch 

Sarah McCullough 

Tracey Sanford 

May 27, 1998 

The test substance was stored at room temperature in a locked cabinet before and after each analysis 

was performed. 

PURPOSE 

The purpose of this study was to determine the weight percent purity, weight percent water, and 

weight percent volatiles. 

MATERIALS AND METHODS 

Purity Determination Procedure 

Titration: 

Approximately 0.25 grams of the test substance was weighed into a titration vessel. The test 

substance was dissolved in I 0 mL of acetic acid and then 200 rnL acetic anhydride was added. 

The test substance was analyzed in triplicate by potentiometric titration. 

Page 9 of 19 L8329-PKV 

81 
\Veight Percent Water Determination Procedure 

Approximately 0.2 grams of the test substance was weighed, transferred to an A QUAST AR® 

V5000 volumetric titrator, and mixed with AQUASTAR® Methanol. The mixnrre was stirred 

until the test substance was dissolved, then titrated. 

Weight Percent Volatiles Determination Procedure 

Approximately 2 grams of the test substance was placed into a pre-weighed aluminum dish. The 

dish with the test substance was placed on the moisture analyzer. The weight percent volatiles of 

the test substance at 105 oc was calculated using the Denver IR-1 00 Moisture Analyzer. The 

initial weights, final weights, drying temperatures and percent volatiles results were recorded. 

\Veight Percent Methanol and Acetone Determination Procedure 

Approximately 1 gram of the test substance was weighed into a 1 00-mL volumetric flask. The 

flask was filled to volume with acetonitrile, and analyzed using GC/FID. A stock solution wasprepared by adding approximately one gram of both methanol and acetone to a 1 00-mL 

volumetric flask ana diluting to volume with acetonitrile. This stock was diluted to yield 

concentrations ranging from 0.1 to 1000 mg!L and analyzed using GC/FID. 

Instrument Conditions 

Titration Test Conditions: 

Instrument: 

Indicating Electrode: 

Reference Electrode: 

Metrohm 670 Titrator 

Corning pH 

Orion Double Junction filled with 10% TMAC 

(tetramethylammonium chloride) 

Titrant: 

Dosimat Rate: 

0.1025 N HCI04 (perchloric acid) in HOAC (glacial acetic acid) 

1.0 mL/rninute 

Buret Volume: lOmL 

Weight Percent Water Determination: 

Instrument: AQUASTAR® V5000, Volumetric Titrator 

Titrant: AQUASTAR® Comp-2, Karl Fischer Reagent 

Titrant Factor 2.4575 mg water/mL titrant 

Solvent: A QUAST AR® Methanol 

Weight Percent Volatiles Determination: 

Instrument: Denver Instrument IR-1 00 Moisture Analyzer 

Test Temperature: 105 oc 

Slope: 0.05%@ 1 minute 

Page10ofl9 L8329-PKV ) 
Weight Percent Methanol and Acetone Determination: 

The samples were analyzed by GCIFID using the following instrument conditions: 

Instrument: 

Column: 

Injection Size: 

Initial Head Pressure: 

Canier: 

Detector Temp.: 

Injector Temp.: 

Oven Conclitions: 

Initial Temp 

(OC) 

35 

Calculations 

Weight Percent Purity: 

Hewlett Packard Model 5890 GCIFID 

DB Wax, 30 ~ 0.32 mm i.d., 0.25 ~rn film thickness 

1 ~L split injection 

7.5 psig 

Helium 

300 oc 

250 oc 

Hold Time Rate (°C/min.) Final Temp. (°C) 

(min.) 

2 10 . 200 

Final Time 

(min.) 

1 

The weight percent purity of the test substance was determined based on the number of test 

substance rnilliequivalents titrated with 0.1025 N HC104 . 

Weight Percent Water: 

The weight percent water was calculated by multiplying the factor of titrant (mg water/mL) by the 

quantity of titrant used for the titration of the sample (rnL), dividing by the sample weight (mg), 

and multiplying the quotient by 100. Calculations were performed using an AQUASTAR® V5000 

volumetric titrator. 

Weight Percent Volatiles: 

The weight percent volatiles of the test substance was calculated by comparing the weight of the 

test substance (grams) at timed intervals (seconds) during a drying process to the initial test 

substance weight (grams). The final weight of the test substance was subtracted from the initial 

weight of the test substance, and the result was divided by the initial weight of the test substance 

and multiplied by 100. Calculations were performed using a Denver Instnunent IR-1 00 Moisture 

Analyzer. 

Weight Percent Methanol and Acetone: 

The estimated method detection limit of methanol and acetone was calculated by multiplying the 

instrument detection limit by 100 rnL, dividing by the amount of test substance in micrograms, and 

multiplying this quotient by 100 percent. 

Page 11 of 19 L8329-PKV 

89 
Protocol and Standard Operating Procedure Deviations 

There were no deviations noted. 

Data Storage and Record Retention 

All original protocols, raw data, and reports will be stored for at least ten years by the Chemicals 

Quality Services Divisio~ Building 320 of the Eastman Kodak Company, Kodak Park, Rochester, 

New York 14652-6276. 

RESULTS 

Weight Percent Purity 

The results of the purity analysis by potentiometric titration were as follows: 

Replicate . Weight Percent Purity (wt %) 

#1 100.4 

#2 99.76 

#3 99.27 

Mean= 99.8 I Standard deviation = 0.58 I Coefficient of Variation(%)= 0.581 

Weight Percent Water 

The results of the weight percent water analyses were: 

Replicate Weight Percent Water (wt %) 

#1 0.7116 

#2 0.6817 

#3 0.6798 

J\Iean = 0.69 t Standard deviation= 0.018 I Coefficient of Variation (%) = 2.6 

Weight Percent Volatiles 

The results of the weight percent volatiles analyses were: 

Replicate Weight Percent Volatiles (wt %) 

#I 0.78 

#2 0.96 

#3 0.90 

Mean= 0.88 I Standard deviation= 0.092 I Coefficient of Variation (%)= 10.5 

Page 12 ofl9 18329-PKV 

go . ' 

,. 
( 

Weight Percent Methanol and Acetone 

The results of the weight percent methanol and acetone are reported as less than the estimated 

method detection limits since no peaks for either solvent were detected above the instrument 

detection linllt in the test substance chromatogram. The weight percent methanol and acetone in 

the test substance was determined to be less than 0.01 and 0.001, respectively. 

CALCULATIONS 

Weight Percent Purity(~/o) = M (N) (W~ x 100 

w. 

where, V =volume of titrant for sample (mL) minus the volume of titrant for blank 

(mL) minus the volume of titrant for the impurity (mL) 

N =normality of titrant (milliequivalents/mL) = 0.1025 meq/mL HC104 

W eq =milliequivalent weight of test substance= 442 mg/meq 

W, = weight of sample (mg) 

e.g. Replicate 1 

Weight% Purity= (6.090mL- 0.020mL- 0.358mL) (0.1025 meq/mL) (442 mg!meg) X 100 

257.7 mg 

= 100.42 wt% 

Weight Percent Water (wt%) = F1 x titer x I 00 

Size 

where, Fl =Factor of Titrant (mg water/mL) 

titer= Quantity of reagent used for titration (mL) 

Size= Sample weight (mg) 

e.g. Replicate I 

Weight Percent Water= 2.4575 x 0.6I5 x 100 = 0.7II6 wt% 

212.4 

Page 13 of 19 L8329-PKV 
Weight Percent Volatiles (wfl/o) = 

e.g. Replicate 1 

initial weight of sample(g)- final weight of sample(g) 

initial weight of sample(g) 

2.055-2.039 X 100 = 0.78 ~/o 

2.055 

Weight Percent Methanol and Acetone (~/o) = 

X 100 

instrument detection limit (ug/mL) x 100 rnL x 100% 

amount test substance (ug) 

e.g. Methanol 

Weight Percent Methanol= 0.5 x 100 x 100 = 0.005 wt% = 0.01 wt% 

1.005g X 1,000,000ug/g 

DISCUSSION 

The test substance was analyzed for purity on June 23, 1998 using potentiometric titration with 

0.1 N HC104 • The mean weight percent of the test substance was 99.8. A titration curve of the 

test substance solution is sho"Ml in Figure I (page 15 of 19). A titration curve of the blank 

solvent is shown in Figure II (page 16 of 19). ) 

The test substance was analyzed in triplicate for weight percent water on an AQUASTAR® VSOOO 

Karl Fischer titrator. The mean weight percent water was 0.69. 

The test substance was analyzed in triplicate at 105 oc for weight percent volatiles using a Denver 

Instrument IR-1 00 moisture analyzer. The weight percent volatiles at 105 °C was 0.88. 

The test substance was analyzed for weight percent methanol and acetone on July 9, 1998 using 

GC/FID. The weight percent methanol and acetone was less than 0.01 and less than 0.001, 

respectively. The remaining 0.19 weight percent volatiles were not identified. 

CONCLUSION 

The purity of the test substance was 99.8 weight percent using potentiometric titration. The mean 

weight percent water was determined to be 0.69. The mean weight percent volatiles at 105 °C was 

determined to be 0.88. The weight percent methanol and acetone was less than 0.01 and less than 

0.001, respectively. The remaining 0.19 weight percent volatiles were not identified. 

Page 14 of19 LS329 PKY ) 
( 

FlGUREI 

TITRATION CURVE OF TEST SUBSTANCE 

Millivolts 

Page15ofl9 

600 

I 

6613 

I 

720 

I 

780 8iu 

I 

L8329-PKV 
FIGURED 

TITRATION CURVE OF BLANK SOL VENT 

( 

~ ... ).1 ~ ... . 

~ 

6ee 

I 

660 

I 

Millivolts 

Page 16 of 19 

729 

I 

?Sa 

I 

s-.e 

I 

900 

I 

L8329-PKV ) 
( 

n ~~ 

103.0 

.: I· 

~ 

,-, I. -

- . ll 

,. 

FIGURE ill 

CHROMATOGRAM OF BLANK ACETONITRILE 

. 

R 

.~ ' ' ~ ' .... ~ :·. u J. _, 1 J. ll 1 ~ __ ; 14 . } 

Page 17 ofl9 

95 

..----

1 b.,, 18. c F:T 

L8329-PKV 
) 

FIGURE IV 

CHROMATOGRAM OF METHANOL AND ACETONE STANDARD IN 

ACETONTinULE J 

108.0 

! l 4 . :J 

/HeJ:i 

1 o > o L_IlLJL_jl _ _I_.P.)....---~-~-----------l ) 

=· ,li 4. 0 6.0 8. II i 4. 0 It. 0 1 2. ·I -· 

Page 18 of19 L8329-PKV ) 
( 

rr ~ 

1 0 3. 0 

• I_ L • !I 

J.IJ 

FIGURE V 

CHRO.MATOGRAM OF TEST SUBSTANCE IN ACETONITRILE 

l 

' I 

-. l 

[.)._ 

4.0 -

~ 

8. 0 I J. 0 ~ 14. 0 1 6. 0 18. I ~:: 

Page 19 of 19 L8329-PKV 
c CONFIDENTIA~ 

FINAL REPORT 

ULTRAVIOLETNISIBLE LIGHT SPECTROSCOPY 

GUIDELINE 

OECD, Section 1, No. 101 

AUTHOR 

Mark A. Dulaney 

TESTING FACILITY 

Environmental Analytical Services 

Chemicals Quality Services Division 

Manufacturing Quality Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652-6276 

USA 

STUDY SPONSOR 

Eastman Kodak Company 

Report No.: L8329-SUV 

STUDY COMPLETION DATE 

July 1{1998 
CONFIDENTIAL 

ANALYTICAL QUM.IT'Y ASSUAANC~ INSPECTION STAT~ 

(CFR S8.3S(B) (7) 792.3S(B) (7) l60.3S(B) (7)) 

STUDY: STUDY DIRECTOR: WU: .. szcz-a, L 

ANAL 'iT I CAL D I REC'l:OR: 

CQS JOB NUMBER: 

STUDY TY.PE: W-VlS ABSORPTION SPECTRA 

(AUDITOR, QUALITY ASSURANCE UNIT) 

THE FOLLOWING PHASES OF THIS STUDY WERE INSPEC!E.D BY ONE OR MORE P~ONS OF 

THE QUALITY ASSURANCE UNIT OH THE OATES LISTED BI!:.LOW. WRITTDI STATUS REPORTS 

lfE.RL SUBMITTED TO THE STUDY DIRECTOR AND APPROPRIATE K}V{AGEXENT. 

INSPECT 

DATES 

06/10/98 

06/10/98 

07/14/98 

REQUEST 

NUMBER 

PHA.SE(S) 

INSPECTED 

PROTOCOL SUBMISSION 

CRI,lJVV 

PHASE DISPEC!ION 

CRI,lJVV 

TEST REP<>RT INSPECTION 

CRI,W 

Page 2 of17 

STATUS REPORT 

DATES 

06/10/98 

06/10/98 

07/H/98 

L8329-SUV 

) 
GOODLABORATORYPRACTICECO~LUNCESTATEMENT 

( 7llis :>i:uJy was conducted according to: 

( 

(_ 

United States Food and Drug Administration, Good Laboratory Practice for Nonclinical 

Laboratory Studies, 21 CFR Part 58; 

United States Environmental Protection Agency, Toxic Substance Control Act, Good 

Laboratory Practice Standards, 40 CFR Part 792.; 

Annex 2 of the Organization for Economic Cooperation and Development, Guidelines for 

Testing of Chemicals [C(81)30(Final)]. 

Study Director 

Page 3 of 17 L8329-SUV 

/60 
SIGNATURE PAGE 

, 

• 

M~nth!Day/Y ear 

Study Director 

\ 

! 

Page 4 of 17 ID I L8329-SUV 
TABLE OF CONTENTS 

( Page 

TABLE OF FIGURES 6 

ABSTRACT 7 

STUDY AND TEST SVBST ANCE INFORMATION 8 

Testing Facility 8 

Sponsor 8 

Sponsor Representative 8 

Study Dates 8 

Project Participants 8 

Test Substance Characterization 8 

Test Substance Storage 9 

PURPOSE 9 

MATERIALS AND METHODS 9 

Test Solution Preparation and Test Conditions 9 

Test Monitoring IO 

Instrument Conctitions IO 

Calculations 10 

Protocol and Standard Operating Procedure Deviations II 

Data Storage and Record Retention I1 

( RESULTS 1I 

Neutral Water 1I 

Acictic Water 1 I 

Basic Water II 

pH ofTest Solutions 12 

CALCULATIONS 12 

Equation for Converting mg!L to moleJL 12 

Equation for Molar Absorption Coefficient 12 

Equation for Bandwidth 12 

Representative Calculations 12 

DISCUSSION 13 

CONCLUSION 13 

REFERENCES 13 

( 

' 

Page 5 of17 Jo?..., L8329-SUV 
TABLE OF FIGURES 

' 

Figure 1. Test Substance in Neutral Water 14 

Figure2. Test Substance in Acidic Water .. 15 

Figure 3. Test Substance in Basic Water 16 

Figure 4. Holmium Oxide - (SRM 2034) 17 

) 

) 

Page 6 of 17 /03 L8329-SUV 
( 

( 

CONFIDENTIAL 

ULTRA VlOLETNISIBLE LIGHT SPECTROSCOPY 

ABSTRACT 

The ultraviolet/visible (UVNis) light spectroscopy of the test substance was studied in conformance 

with Annex 2 of the OECD Guidelines for Testing of Choocals (C(81 )30(Fina1)), as outlined by 

OECD Gilldeline 101. The test substance was found to be readily soluble in water (water refers to 

rugh purity water wruch is used throughout the remainder of the report). Three working solutions 

were prepared by diluting the test substance stock solution into neutral water, acidic water, and 

basic water. The spectra of the test substance in the three matrices were obtained. The absorbance 

maxima from the spectra were used to determine bandwidths and molar absorption coefficients for 

the three matrices. The results of the ultraviolet/visible light spectra indicate that the test substance 

may be susceptible to photocherrUcal degradation. 

Page 7 of 17 L8329-SUV 
. CONFIDENTIAL 

STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

Environmental Analytical Services 

Cbemi cals Quality Services Division 

Manufacturing Qua]jty Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652-6276 -

USA 

Sponsor: Eastman Kodak Company 

Sponsor Representative 

Julie Byrne 

Eastman Kodak Company 

Rochester, New York 14652-6267 

Study Dates 

Study Start Date: 

Experiment Start Date: 

Experiment Completion Date: 

Project Participants 

Study Director 

Principal Investigator 

Repon Author 

Test Substance Characterization 

Received into Laboratory: 

June 10, 1998 

June 11, 1998 

June 11,1998 

Lori J. Wieszczyk 

Mark A. Dulaney 

Mark A. Dulaney 

May 27, 1998 

Page 8 of 17 

Jot; L8329-SUV 

) 
Test Substance Storage 

( The test substance was stored at room temperature in a locked cabinet before and after use. 

( 

( 

PURPOSE 

The purpose of this test was to determine the UV Nis absorption spectrum of the test substance. 

The information obtained was used to calculate bandwidths and molar absorption coefficients. 

These properties characterize the energy absorbed at various wavelength regions where the test 

substance may be susceptible to photochemical degradation. 

MATERIALS AND METHODS 

Test Solution Preparation and Test Conditions 

A test substance stock solution was prepared by diluting the test substance into water. Three 

working solutions were prepared by diluting the test substance stock solution into neutral, acidic and 

basic water. 

The acidic water diluting solvent was prepared by adding 20.0 mL of one (1) molar hydrochloric 

acid solution to a 200-mL volumetric flask and diluting to volume with water. 

The basic water diluting solvent was prepared by adding 20.0 mL of one (1) molar sodium 

hydroxide to a 200-m.L volumetric flask and diluting to volume with water. 

The neutral water solvent used for the analysis was purified water. 

The stock solution was prepared by weighing 0.2028 grams of the test substance into a 1 00-mL 

· volumetric flask and diluting to volume with purified water. 

The test substance representations were prepared using aliquots of the test substance stock solution 

to generate three solutions that, when analyzed, yielded spectra that bad at least one peak with an 

absorbance unit between 0.5 and 1.5. The neutral test substance representation was prepared by 

diluting 200 )lL of the stock solution to 25 milliliters with the neutral purified water, final 

concentration of 16.22 rng!L. The acidic test substance representation was prepared by diluting 400 

)lL of the stock solution to 25 milliliters with the acidic water, final concentration of 32.448 mg!L. 

The basic test substance representation was prepared by diluting 2000 )lL of the stock solution to 25 

milliliters with the basic water, final concentration of 162.24 mg!L. The acidic and basic water 

diluting solvents were used as the background correction and blank solutions for the acidic and 

basic test substance solutions, respectively. Water was used as the background correction and blank 

solution for the neutral test substance solution. 

Page 9 of 17 /Dlo L8329-SUV 
Test Monitoring 

The study was carried out at 22.3 oc_ 

Instrument Conditions 

The solutions were analyzed using the following conditions: 

Instrurn ent: 

Data Collection Mode: 

Scan Range: 

Scan Speed: 

Slit: 

Data Interval: 

Cells: 

Perkin Elmer Lambda 40 Spectrophotometer 

with Perkin Elmer UV WmLab® software 

Absorbance 

Wavelength Max. 900 nanometers (nm) 

Wavelength Min. I 90 nm 

480 nm/minute 

2.0nm 

I nm 

1.0 centimeter (em) quartz 

, 

A weekly holmium oxide standard was analyzed to ensure the instrument was performing properly. 

See Figure 4 (page I 7 of I 7) for the ultraviolet/visible light spectrum of the holmium oxide 

standard. 

Calculations 

The concentration of the test substance in mole!L was calculated by converting the units of 

concentration from mg!L to giL and then converting to mole/L by relating this concentration to the 

molecular weight of the test substance. The calculations were performed using a Microsoft® Excel 

spreadsheet 

The molar absorption coefficient was calculated at each wavelength where a maximum absorbance 

was obtained for the test substance. The molar absorption coefficient was expressed in Llmole·cm. 

The calculations were performed using a :Microsoft~xcel spreadsheet. 

The band'Nldth for each absorbance maximum capable of being resolved was measured. The 

band'Nldth was expressed in nanometers (nm). The calculations were performed using a Microsoft® 

Excel spreadsheet and Perkin Elmer UV WinLab® software. 

Page IO of I7 !07 L8329-SUV 

) 
( 

( 

( 

Protocol and Standard Operating Procedure Deviations 

There were no protocol or standard operating procedure deviations noted for the study. 

Data Storage and Record Retention 

All original protocols, raw data, and reports will be stored for at least ten years by the Chemicals 

Quality Services Division, Building 320 of the Eastman Kodak Co., Kodak Park, Rochester, New 

York 14652-6276. 

Absorbance Max. 

(run) 

190 

Absorbance Max. 

(run) 

201 

Absorbance Max. 

(nm) 

215 

RESULTS 

Neutral Water 

Molar Absorption Coefficient 

(Umole·cm) 

1.63·104 

Acidic Water 

Molar Absorption Coefficient 

(Umole·cm) 

9.32·103 

Basic Water 

Molar Absorption Coefficient 

(Umole·cm) 

2.11·103 

nd = not determined, absorbance peak was not resolved 

Page 11 of 17 

/Of{ 

Bandwidth 

(nm) 

nd 

Bandwidth 

(run) 

13.79 

Bandwidth 

(run) 

9.32 

L8329-SUV 
pH of Test Solutions 

Solution Identification pH 

Test Substance Stock 10.06 

Neutral Test Solution 7.70 

Acidic Test Solution 1.06 

Basic Test Solution 13.44 

Water 5.99 

CALCULATIONS 

Equation for Converting mg!L to mole/L: 

concentration (mole/L) = [x](rng/L) x (1 g I I 000 mg) I MW 

Where; [x] =concentration of the test substance solution, (mg!L) 

(MW) =test substance molecular weight= 442.0 g I mole. 

Equation for Molar Absorption Coefficient: 

Molar Absorption Coefficient =_A_ 

cxd 

Where; A =Absorbance at a maximum wavelength 

c =Concentration of the test substance solution (moleiL) 

d =Path length of the spectrophotometer cell (I em) 

Equation for Band-width: 

Bandwidth = right side (nm) - left side (nm) 

Where; right side (run)= the wavelength at 1/2 the absorbance maxima on the right side of the peak 

left side (nm) =the wavelength at 1/2 the absorbance maxima on the left side of the peak 

Representative Calculations: 

The test substance calculations represent the acidic water sample at 20 I nm. 

Concentration (mole/L): 

32.4 mg/L x I g/I 000 mg I ( 442.0 g I I mole)= 7.33 x I o·5 moleJL 

Page 12 of 17 /09 L8329-SUV 
( 

( 

( 

Molar Absorption Coefficient: 

0.68344 = 9.32 x I<Y Umo}excm ___ 7 ___ 3_3_x_l_o~-s-m_o_l_dL ____ __ 

Bandvvidth: 

211.47 nm - 197.68 run = 13.79 nm 

DISCUSSION 

Prior to each analysis a background correction was performed with a "blank solution" of the 

appropriate test substance diluting solvent Figure 1 (page 14 of 17) shows the ultraviolet'visible 

light spectrum for the test substance in neutral water. The ultraviolet/visible light spectrum for the 

test substance in acidic water is shown in Figure 2 (page 15 of 17). Figure 3 (page 16 of 17) shows 

the ultravioletlvisible light spectrum for the test substance in the basic water. Using these spectra 

with the absorbance maxima information, the respective bandwidths and molar absorption 

coefficients were calculated. The test substance in all three matrices exhibited similar spectra. The 

test substance clid not exhibit an absorbance above 300 run in any of the three matrices. The 

ultravioletlvisible light spectrum of the test substance in the neutral matrix bad a peak maximum at 

approximately 190 run. The ultraviolet/visible light spectrum of the test substance in the acidic 

matrix bad a peak maximum at approximately 200 run. The ultraviolet/visible light spectrum of the 

test substance in the basic matrix bad a peak maximum at approximately 215 nm. All test substance 

solutions were clear and colorless. 

CONCLUSION 

The results of the ultravioletlvisible light spectra indicate that the test substanoe may be susceptible 

to photochemical degradation. 

REFERENCES 

1. Organization for Economic Cooperation and Development (OECD)1981. "Ultraviolet/Visible 

light Spectroscopy'' (I 01). OECD Guidelines for Testing of Chemicals. 

Page 13 of 17 /JO L8329-SUV 
FIGURE 1 

' \ 

Test Substance in Neutral Water ) 

0 

,g 

0> 

0 

II) 

<X) 

0 

0 

<X) 

r~ I 

I 

10 

~o 

i~"-

0 

II) 

<.0 

,0 

:--0 

I <.0 

lo 

'- \l) E <r>c 

:_g 

' ll) 

I 

I 

: 

. 0 

-ll) 

'v 

'o '-o v 

. 0 L.n 

,..., 

,..., 

Ls 

10 I r~ I 

I 

I Lo 

0 

m 0 <.0 \l) v ..., N 0 ,..... 0 0 0 0 0 0 0 0 c? 

<( 

) 

Page 14 ofl7 /II L8329-SUV 
( 

( 

( 

FIGURE2 

Test Substance in Acidic Water 

0 

,~ 

I 

I~ 

'o Lo 

' .... I 

10 

>-0 

<D 

0 c-o 

' 1() 

'O LQ 

,"¢ 

I 

I 

10 

rg 

-~- lq r----r----.---~--~~~~~~-r~--.---~----~~ = 

o r-. ~ 1() • n N o o~ 

~ 0 0 0 0 0 0 0 0 0 

< 

E 

c: 

Page 15 ofl7 1/:J. L8329-SUV 
0 

0 0'> 

ci 

FIGURE3 

Test Substance in Basic Water 

co 

ci 

/ 

---

·0 

:-o 

' 00 I 

0 -o 

<.D 

0 ~o 

.,., 

0 -o 

.... 

0 -0 

'("') 

---=.-..=-...::_--

------ _-_-_-_-=._-::_-~-=~~--0 

ID 

ci 

----------===o 0'> '<r M N 0 0 

0 0 ci ci ci ci 

9 

< 

E 

c:: 

Page 16 of 17 /13 L8329-SlN 

) 

) 
F1GURE4 

(_ Holmium Oxide- (SRM. 2034) 

-----

( -

--------

( 

Page 17 of 17 

-

I 

I 

0 

0 

0 

1'-

0 

I() 

10 

0 

0 

10 

l_~ I(} 

IO 

~o 

I I() 

i 

'0 rl() 

,.., 

0 -o / . .., 

,a 

-I() :["') 

l 

i 

•0 t-O 

I["') 

! 

E 

<: 

L8329-SUV 
I 

\ 

' 

Final Report CONFIDENTIAL 

ANALYSIS BY INFRARED SPECTROSCOPY 

Author 

Christine M. Hoffinan 

PERFORNITNGLABORATORY 

Environmental Analytical Services 

Chemicals Quality Services Division 

Manufacturing Quality Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652-6276 

USA 

STUDY SPONSOR 

Eastman Kodak Company 

Rochester, NY 14652-6267 

USA 

Report Number. L&329-SIR 

STIJDY CO:MPLETION DATE 

J ~A;ItlY ,/ 7/' / 

/IS 
CONFIDENTIAL 

ANALYTICAL QUALITY ASSURANCE INSPECTION STATEMENT 

(CFR 58.35(B) (7) 792.35(B} (7) 160.35(B} (7)) 

STUDY: STUDY DIRECTOR: HOFFMAN,C 

ANALYTICAL DIRECTOR: 

KAN : 

CQS JOB NUMBER: 

STUDY TYPE: INFRARED SPECTROSCOPY 

O'fa.di.f ·Yllc(cftLJv 

(AUDITOR, QUALITY ASSURANCE UNIT) 

THE FOLLOWING PHASES OF THIS STUDY WERE INSPECTED BY ONE OR MORE PERSONS OF 

THE QUALITY ASSURANCE UNIT ON THE DATES LISTED BELOW. ~TTEN STATUS REPORTS 

WERE SUBMITTED TO THE STUDY DIRECTOR AND APPROPRIATE MANAGEMENT. 

INSPECT 

DATES 

06/18/98 

07/09/98 

REQUEST 

NUMBER 

PHASE { S) 

INSPECTED 

PROTOCOL SUBMISSION 

CRI, IR 

TEST REPORT INSPECTION 

CRI, IR 

Page 2 of 12 lifo 

STATUS REPORT 

DATES 

06/18/98 

07/09/98 

L8329-SIR 
( 

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

The study was conducted according to: 

United States Food and Drug Administration, Good Laboratory Practice for Nonclinical 

Laboratory Studies, 21 CFR Part 58; 

United States Environmental Protection Agency, Toxic Substances Control Act, Good 

Laboratory Practice Standards, 40 CFR Part 792; 

Annex 2, Organization for Economic Cooperation and Development, Guidelines for Testing 

of Chemicals [C(81)30(Fina1)]. 

~tine M. Hoffman 

Study Director 

Page 3 of 12 /17 

ay/Year 

L8329-SIR 
SIGNATURE PAGE 

) 

feM.Byme U 

Sponsor Representative 

Page 4 of 12 //8 L8329-SIR 
( 

. TABLE OF CONTENTS 

ABSTRACT 

STUDY AND TEST SUBSTANCE INFORMATION PAGE 

Testing Facility 

Sponsor 

Sponsor Representative 

Study Dates 

Project Participants 

Test Substance Characterization 

Test Substance Storage 

PURPOSE 

MATERIALS AND 1\IETHODS 

Instrument Conditions 

Sample Preparation 

Protocol and Standard Operating Procedure Deviations 

Data Storage and Record Retention 

RESULTS 

Page 

6 

7 

7 

7 

7 

7 

7 

7 

7 

8 

8 

8 

8 

8 

8 

9 

DISCUSSION 9 

CONCLUSIONS 9 

REFERENCES 10 

FIGURE I 

FITR SPECTRUM OF TEST SUBSTANCE 11 

FIGURE II 

FTIR SPECTRUJ\-'1 OF TEST SUBSTANCE WITH PEAK FREQUENCIES 12 

Page 5 of 12 /19 L8329-SIR 
CONFIDENTIAL 

ABSTRACT 

A Fourier transform infrared (FTIR) spectrum was obtained in conformance with standard 

operating procedure CQS/EAS/NCS-QOD-0121-0l. A mixture of the test substance in dried 

potassium bromide (KBr) was scanned from 4000-400 cm·1 using a Perkin Elmer (PE) 1725 X 

FTIR spectrophotometer. The spectrum of the test substance was determined to be consistent 

with the proposed structure by assigning the major functional groups. 

Page 6 of12 /~D L8329-SIR 

) 
( 

CONFIDENTIAL 

STUDY AND TEST SUBSTANCE INFORMATION PAGE 

Testing Facility 

Environmental Analytical Services 

Chemicals Quality Services Division 

Manufacturing Quality Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652-6276 

USA 

Sponsor 

Eastman Kodak Company 

Rochester, New York 14652-6267 

USA 

Sponsor Representative 

Julie M. Byrne 

Study Dates 

Study Start Date: 

Experiment Start Date: 

Experiment Completion Date: 

June 16, 1998 

June 16, 1998 

June 18, 1998 

Project Participants 

Study Director: 

Study Analyst: 

Report Author: 

Christine M. Hoffman 

Christine M. Hoffinan 

Christine M. Hoffman 

Test Substance Characterization ~ 

Test Substance Name: 

KAN: 

HAEL Number: 

Sample Ref. Number.: 

CAS Registry Number: 

CIN: 

Date Sample Received: May 27, lY98 

Test Substance Storage 

The sample was stored in a locked cabinet at room temperature prior to analysis. 

Page 7 of 12 /~} L8329-SIR 
PURPOSE 

The purpose of this experiment was to determine if the FTIR spectrum of the test substance was 

consistent with the kno\VTl structure of the test substance. This was done by assigning the infrared 

absorption bands of the spectrum to major functional groups and comparing the as,:ignrnents to the 

proposed structure of the test substance. 

MATERIALS AND l'riETHODS 

Instrument Conditions 

A FTIR spectrum of the test substance was collected using the following instrument conditions: 

Instrument: 

Detector: 

Scan Range: 

Resolution: 

Number of Scans: 

Sampling Technique: 

Perkin Elmer (PE) 1725 X FTIR Spectrophotometer 

Fast Recovery Deuterated Tri-Giycine Sulfate (FR-DTGS) 

4000-400 em·' 

4.0cm·' 

16 

Transmission (KBr pellet) 

A background spectrum of dried KBr in pellet form was obtained prior to acquiring the test 

substance spectrum. 

Sample Preparation 

A mixture of the test substance in dried KBr was prepared such that the intensity of at least one 

peak in the spectrum covered 25% of the transmittance scale without any peak actually reaching 

0% transmittance. The mixture was analyzed using transmission FTIR spectroscopy by means of a 

KBr pellet. 

Protocol and Standard Operating Procedure Deviations 

There were no deviations from the protocol or standard operating procedures. 

Data Storage and Record Retention 

All original raw data will be retained for a minimum often years in the Chemicals Quality Services 

Division archives of the Eastman Kodak Co., Building 320, Kodak Park. 

Page 8 of 12 L8329-SIR 
( 

RESULTS CONFIDENTIAL 

A FTIR spectrum was obtained and the spectral band assignments are as follows: 

DISCUSSION 

Infrared vibrations in complex molecules couple and mix strongly with one another, therefore, 

some spectral bands remain unassigned. 

The spectral band assignments were consistent with the known structure of the test substance. See 

pages 11 and 12 for FTIR spectra of the test substance. 

CONCLUSION 

The spectral band assignments were consistent with the known structure of the test substance. 

Page 9 of 12 L8329-SIR 
REFERENCES 

The following references were used as spectral interpretation aids: 

The Aldrich Library Of Infrared Spectra, Edition III; Pouchert, Charles, Ed. 1981 

Silverstein, Bassler, and Morrill Spectrometric Identification of Organic Compounds, Fifth Edition; 

John Wiley and Sons, 1981 

LJ. Bellamy The Infrared Spectra ofComplex Molecules, Vol. I, Chapman and Hall; Third 

Editio~ 1975. 

Page 10 of 12 L8329-SIR 
CON Fl D ENTIAL 
CONFIDENTIAL 
.. 

CONFIDENTIAL 

FINAL REPORT 

ANALYSIS BY NMR SPECTROSCOPY 

AUTHOR 

Christine M. Hoffman 

TESTING FACILITY 

Environmental Analytical Services 

Chemicals Quality Services Division 

Manufacturing Quality Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652-6276 

USA 

STUDY SPONSOR 

Eastman Kodak Company 

Report Number: L8329-N11R 

STIJDY COMPLETION DATE 

/J7 
ANALYTICAL QUALITY ASSURANCE INSPECTION STATEMENT 

(CFR 58.35(8) (7) 792.35(8) (7) 160.35(8) (7)) 

STUDY: _____ STUDY DIRECTOR: STAUDENMi\YER, K 

ANALYTI~ DIRECTOR: 

KAN : 

CQS JOB NUMBER: 

STUDY TYPE: NMR SPECTROSCOPY 

(AUDITOR, QUALITY ASSURANCE UNIT) 

TifE FOLLOWING PijASES OF THIS STUDY WERE INSPECTED BY ONE OR MORE PERSONS OF 

THE QUALITY ASSURANCE UNIT ON THE DATES LISTED BELOW. WRITTEN STATUS REPORTS 

WERE SUBMITTED TO THE STUDY DIRECTOR AND APPROPRIAT!: MANAGEMENT. 

INSPECT REQUEST PHASE (S) STATUS REPORT 

DATES NUMBER INSPECTED DATES ------- ------- --------- ----------- 06/03/98 PROTOCOL SUBMISSION 06/03/98 

CRI,NMR 

07/23/98 TEST REPORT INSPECTION 07/23/98 

CRI,NMR 

Page 2 of 14 L8329-N?vfR 

) 
GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This study was conducted according to: 

Uruted States Food and Drug Administration, Good Laboratory Practice for Nonclinical 

Laboratory Studies, 21 CFR Part 58; 

Uruted States Environmental Protection Agency, Toxic Substances Control Act, Good 

Laboratory Practice Standards, 40 CFR Part 792; 

Annex 2, Orgarlization for Economic Cooperation and Development, Guidelines for Testing of 

Cherrlicals [C(81 )30(Final)]. 

Kathy Staudenmayer 

Study Director 

~e 

Cl.J,: m ~ 

Sponsor Representative 

Page 3 of 14 

M 2Y,/99S 

Month!Day/Y ear 

L8329-NI\1R 

1~9 
SIGNATIJRE PAGE 

~ 2.<-t, /198 

Month!Day/Y ear 

Study Director 

Page 4 of 14 /30 L8329-NMR 
TABLE OF CONTENTS 

ABSTRACT 

STUDY Al'ID TEST SUBSTANCE II~rORMATION 

Testing Facility 

Sponsor 

Sponsor Representative 

Study Dates 

Project Participants 

Test Substance Characterization 

PURPOSE 

MATERIALS AND METHODS 

Test Solution Preparation and Test Conditions 

Protocol and Standard Operating Procedure Deviations 

Data Storage and Record Retention 

RESULTS 

DISCUSSION 

CONCLUSION 

REFERENCES 

'H Spectrum 

FIGURES 

Figure I 

Figure II 

Figure ill 

Figure IV 

1

H Spectrum with Assignments 

'H- 1H 2-D COSY Spectrum 

'H-'H 2-D COSY Spectrum with Assignments 

Page 5 of 14 /31 

Page Number 

6 

7 

7 

7 

7 

7 

7 

8 

8 

8 

8 

8 

9 

9 

9 

10 

11 

12 

13 

14 

L8329-NMR 
CONFIDENTIAL 

ANALYSIS BY NMR SPECTROSCOPY 

ABSTRACT 

Nuclear magnetic.resonance (NrvfR) spectroscopy was utilized to determine the structure of the. 

test substance. The test substance was dissolved in deuterated chloroform (CDCl3) with 

trifluoracetic anhydride (TFA) and a one dimensional (1-D) proton CH) N1vfR spectrum and a 

two dimensional (2-D) 1

H -

1

H Correlation (COSY) spectrum were acquired using a Varian 

Gemini 300 MHz N1vfR. spectrometer. The acquired spectra were consistent with the known 

structure for the test substance. Interpretation of the acquired spectra was made by assigning the 

resonance frequencies. 

Page 6 of 14 J3a L8329-NMR 

) 

) 
STUDY AND TEST SUBSTANCE INFORMATION 

Testing Facility 

Synthetic Chemicals Analytical Services 

Chemicals Quality Services Division 

Manufacturing Quality Assurance Organization 

Eastman Kodak Company 

Rochester, New York 14652 

USA 

Sponsor 

Eastman Kodak Company 

Sponsor Representative 

Julie M. Byrne 

Eastman Kodak Company 

Rochester, NY 14652-6267 

USA 

Study Dates 

Study Start Date: June 7, 1998 

Experimental Start Date: June 10, 1998 

Experimental Completion Date: June 10, 1998 

Project Participants 

Study Director: 

Principal Investigator( s ): 

Report Author: 

Kathy Staudenmayer 

William L. Lewis 

Kathy Staudenmayer 

Christine M. Hoffman 

Page 7 of 14 /33 L8329-NMR 
CONFIDENTIAL 

Test Substance Characterization 

, 

Received mto LabOratory: May 27, 1998 

PURPOSE 

Molecular structure information of a chemical substance can be useful in predicting and/or 

understanding its health and environmental properties. N1viR Spectroscopy is widely held as an · 

appropriate analytical methodology for the determination of structural information. One 

dimensional and two dimensional 1

H spectra were acquired for the purpose of elucidating the 

molecular structure of the test substance. 

MATERIALS AND METHODS 

Test Solution Preparation and Test Conditions 

Approximately 50 milligrams of the test substance was dissolved in one milliliter of CDCl3 with 

TF A. The solution was transferred to a 5-rnm NMR tube and placed in the magnet of a Varian 

Gemini high-field NMR spectrometer operating at a proton observation frequency of 

300.06 "MHz. The proton Nrv1R spectra were acquired at a temperature of 30.0 oc and referenced 

to tetramethylsilane (TMS) at zero ppm. 

Protocol and Standard Operating Procedure Deviations 

None. 

Page 8 of 14 L8329-NMR 

v 86 
. 

CONFIDENTIAL 

Data Storage and Record Retention 

All original protocols, raw data, and reports will be retained for a minimum of ten years in the 

Chemicals Quality Services Division archives of the Eastman Kodak Co., Building 320, Kodak 

Park. 

RESULTS 

Approximate Chemical Assignment• 

Shift (ppm) 

:; 

- -

- .., 

I i 

*See F1gure II for spectral assignments. 

DISCUSSION 

The acquired 1-D and 2-D 1H Ntv1R spectra are consistent with the known molecular structure for 

the substance. The assignments of 1

H resonance frequencies in the 1-D NMR spectrum shown m 

Figure II were made on the basis of theoretical cherrilcal shifts and scalar (J) coupling networks 

obtained through the acquisition and subsequent interpretation of the 2-D COSY experiment 

shown ill Figures III and IV. See Figure II for the chemical structure. 

CONCLUSION 

The 1-D and 2-D 1H spectra are consistent with the structure of the test substance. See Figure II 

for the chemical structure of the test substance. 

Page 9 of 14 !3f) L8329-N1vfR 
REFERENCES 

~ 

Silverstein, Bassler, and Morrill, Spectrometric Identification of Organic Compounds, Fourth 

Edition; John Wiley and So~ 1981 

The Sadtler Handbook of Proton NMR Spectra, Editor William W. Simons, Sadtler Research 

Libraries, 1978 

R.J. Abraham, J. Fisher, and P. Loftus, Introduction to NMR Spectroscopy, John Wiley and Sons, 

1988 

Page 10 of 14 L8329-NMR 
CONFIDENTIAL 

131 
CONFIDENTIAL 

138 
CONFIDENTIAL 

/39 
CONFIDENTIAL 

JlJD 
roNFlOENTIAl 

FINAL REPORT 

TS-98-009 

Page 1 of9 

HAELNo.~ KANIH&SNo.(-~ CIN t > ......-----... RANNo.( ' 

---- PHYSICO-CHEMICAL PROPERTIES WITH RESPECT TO SOLID FLAMMABILITY 

GUIDELINE 

Annex To Commission Directive 92/69/EEC Of 31 July 1992, 

Part A: Methods for the Determination of Physico-Chemical Properties 

AUTHOR 

Tracy W. Panczyszyn 

TESTING FACILITY 

Technical Safety Laboratory 

Health and Environment Laboratories 

Eastman Kodak etmpany 

Rochester, New York 14652-6270 

USA 

LABORATORY PROJECT ID 

HAEL Laboratory Number,,: :) 

STUDY SPONSOR 

Eastman Kodak Company 

STUDY COMPLETION DATE 

September 11, 1998 

!'/I 
fONFIDENTIAL 

QUALITY ASSURANCE INSPECTION STATEMENT 

TS-98-009 

Page 2 of9 

{21 CFR 58.35(B) {7), 40 CFR 792.35{B) {7), AND 40 CFR 160.35{B) {7)) 

STUDY: STUDY DIRECTOR: PANCZYSZYN,T.W. PAGE 1 

ACCESSION NUMBER: f 09/08/98 

STUDY TYPE: SOLID FLAMMABILITY 

J1/] · /~ L/l v,,,J 

(AUDITOR, QUAL~Y ASSURANCE UNIT) DATE 

THIS STUDY WAS INSPECTED BY 1 OR MORE PERSONS OF THE QUALITY 

ASSURANCE UNIT. WRITTEN STATUS REPORTS ~ERE SUBMITTED ON THE 

FOLLOWING DATES. 

INSPECTION 

DATES 

PHASE(S) 

INSPECTED 

07/09/98 PROTOCOL SUBMISSION 

07/27/98 TEST SUBSTANCE DISTRIBUTION RECORDS 

FILL MOLD AND IGNITE 

09/08/98 FINAL REPORT REVIEW 

STATUS REPORT 

DATES 

09/08/98 

09/08/98 
TS-98-009 

Page 3 of9 

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This study was conducted according to: 

United States Food and Drug Administration, Good Laboratory Practice for Nonclinical 

Laboratory Studies, 21 CFR Part 58; 

United States Environmental Protection Agency, Toxic Substances Control Act, Good 

Laboratory Practice Standards, 40 CFR Part 792; 

Annex 2, Organisation for Economic Cooperation and Development, Guidelines for 

Testing of Chemicals [C(81 )30(Final)]. 

Month/Day/Year 

!43 
REPORT SIGNATURE PAGE 

TS-98-009 

Page 4 of9 

PHYSICO-CHEMICAL PROPERTIES WITH RESPECT SOLID FLAMMABILITY 

Tracy W. ~fnczyszyn, B.S~ ~ Mo~th/Day/Y ear 

Study Director 

/! 

/ 

Glenn T. Bodman, B.S. Month/Day/Year 

Unit Director, Technical Safety Laboratory 

144 
TABLE OF CONTENTS 

TS-98-009 

Page 5 of9 

Page 

Number 

ABSTRACT 6 

Testing Facility 7 

Project Participants 7 

Sponsor 7 

Test Substance Characterization 7 

Study Dates 7 

Purity Analysis, Structure Confirmation, and Stability Determination 7 

Moisture Content 7 

PURPOSE 7 

FLAMMABILITY (SOLIDS) 8 

Materials And Methods 8 

Results 8 

Discussion 8 

DATASTORAGE 9 

CONCLUSION 9 

;16 
HAELNo.' 

TS-98-009 

Page 6 of9 

ABSTRACT fONFIDENTIAL 

KANNo. ) -------- ----CIN (._ ) RAN No.( --- PHYSICO-CHEMICAL PROPERTIES WITH RESPECT SOLID FLAMMABILITY 

METHODS: EEC Annex to Commission Directive 92/69 EEC of 31 July 1992 Part A: 

Methods for the Determination of Physico-Chemical Properties: 

A.l 0. Flammability (Solids) 

RESULTS: 

Flanunability (Solids): Not Highly Flammable 
TS-98-009 

Page 7 of9 

STUDY AND TEST SUBSTANCE INFO'RMATION 

T~sting Facility 

Technical Safety Laboratory 

Health and Environment Laboratories 

Eastman Kodak Company 

fONFIDENTIAL 

Rochester, New York 14652-6270 

USA 

Project Participants 

Study Director 

Study Technician(s) 

Laboratory Director 

Report Author 

Eastman Kodak Company 

Tracy W. Panczyszyn 

Elizabeth F. Brandt 

Glenn T. Bodman 

Elizabeth F. Brandt 

Sponsor 

Test Substance Characterization 

Test Substance Name: 

HAELNo.: 

KAN/H&S No.: 

CIN: 

SRID or Lot No.: 

Physical State and Appearance: 

Received at Testing Facility: 

Laboratory Project ID: 

Study Initiation Date 

Experimental Start Date 

Experimental Termination Date 

white solid 

June I, 1998 

(_ ) 

Study Dates 

July 8, 1998 

July 27, 1998 

July 27, 1998 

Purity Analysis, Structure Confirmation, and Stability Determination 

Refer to composition information contained in notification. 

Moisture Content 

Refer to composition information contained in notification. 

PURPOSE 

The purpose of this study was to evaluate the physico-chemical properties of the test substance with 

respect to solid flammability. 

;17 
Experimental Design 

FLAMMABILITY (SOLIDS) 

Materials And Methods 

TS-98-009 

Page 8 of9 

This study was conducted by methods comparable to EEC Annex to Commission Directive 92/69 

EEC of 31 July 1992 Part A: Methods for the Determination of Physico-Chemical Properties: 

A.IO. Flammability (Solids). The as received test substance was made into a train of250-mm in 

length and an attempt was made to ignite one end of the train with a gas flame as a preliminary 

screening test. 

According to the Directive: 

1) if in the preliminary screening test combustion by burning or smoldering occurred over a 

200-mm length of the train within four minutes, then a detailed burning rate test would be 

carried out, or 

2) if in the preliminary screening test the test substance did not ignite within two minutes, or 

ignited but failed to propagate combustion either by burning with flame or smoldering along 

the 200-mm powder train within four minutes, then the test substance would be categorized as 

not highly flammable and no further testing would be done. 

The burning rate test was not carried out. 

Test Substance Preparation 

The substance was tested as received. 

Calculations and Statistical Procedures 

Not applicable. 

Protocol and Standard Operating Procedure Deviations 

None. 

Results 

Laboratory Relative Humidity: 52.1 % 

OBSERVATIONS: 

Preliminary Screening Test: Ignition occurred after 32 seconds and propagated 28 mm down 

the train before extinguishing. Combustion did not propagate 

200-mm. 

Discussion 

The test substance was not found to be highly flammable. 
DATA STORAGE 

TS-98-009 

Page 9 of9 

The final report, data sheets, all raw data and an aliquot of the test substance have been stored in 

the testing facility archive managed under GLP-mandated conditions. 

CONCLUSION 

Flammability (Solids): Not Highly Flammable 
COMMERCIAL-IN-CONFIDENCJ;__ 

c ~' 

RISK ASSESSMENT OF 

~~~~~~~f~~NF~I~NTI~L For 

Annex VIIC Notification 

HAELNo.~ 

CAS Registry Number:~ 

CONTRIBUTORS 

Julie M. Byrne 

Willem D. Faber, Ph.D., DABT 

Ruth Hosenfeld 

Linda S. Hickey 

Charles J. Ruffing, Ph.D. 

PLEASE DIRECT ANY QUESTIONS TO: 

Julie M. Byrne 

Health and Environment Laboratories 

Eastman Kodak Company 

1100 Ridgeway Avenue 

Rochester, New York 14652-6267 

U.S.A. 

SPONSOR 

Kodak Limited 

Headstone Drive 

Harrow, Middlesex 

HA1 4TY, UK 

30 September 1998 

/So 
COMMERCIAL-IN-CONFIDENCE 

CONFIDENTIAl TABLE OF CONTENTS 

EXECUTIVE SUMMARY 

RISK ASSESSMENT 

1.0 INTRODUCTION 

2.0 HEALTH ASSESSMENT- TOXICITY 

2.1 HAZARD IDENTIFICATION 

2.1.1 Toxicity Data from Animal Studies 

2.1.1.1 Acute Toxicity 

2.1.1.2 Irritation and Sensitization 

2.1.2 Mutagenicity 

2.1.3 Carcinogenicity 

2.1.4 Reproductive Toxicity 

2.1.5 Repeated Dose Toxicity 

2.1.6 Toxicity Data from Human Studies 

2.2 DOSE-RESPONSE ASSESSMENT 

2.3 EXPOSURE ASSESSMENT 

2.3.1 Introduction 

2.3.2 Occupational Exposure 

2.3.3 Consumer Exposure 

2.3.4 Public Exposure 

2.4 RISK CHARACTERIZATION 

2.4.1 Classification Review 

2.5 INTEGRATION 

3.0 HEALTH ASSESSMENT- PHYSICOCHEMICAL PROPERTIES 

3.1 HAZARD IDENTIFICATION 

3.2 EXPOSURE ASSESSMENT 

3.2.1 Flammability (solids) 

3.2.2 Stability as measured by DSC 

3.3 RISK CHARACTERIZATION 

3.4 INTEGRATION 

-i-

!51 

(-== ~ 

iii 

1 

1 

1 

3 
CONFIDENTIAl 

4.0 ENVIRONMENTAL ASSESSMENT 

4.1 HAZARD IDENTIFICATION 

4.1.1 Toxicity Data 

4.2 DOSE-RESPONSE ASSESSMENT 

4.3 EXPOSURE ASSESSMENT 

4.4 RISK CHARACTERIZATION 

4.5 INTEGRATION 

5.0 OVERALL INTEGRATION OF CONCLUSIONS 

ATTACHMENT 

Differential Calorimetry Scan 

-iiCOMMERCIAL-IN-CONFIDENCE cc= -~ 

4 

5 

NUMBER 

1 
CONFIDENTIAL COMMERCIAL-IN-CONFinFNr.F 

(~ 

EXECUTIVE SUMMARY 

This assessf!Jent of the potential risk to man and the environment for 

}Nas conducted in -:-;-:---,---------::::---:-

support of the submitter's new chemical notification as specified in the Seventh 

Amendment, Articles 1 (1 c), 3 and 7 (92/32/EEC, 30 April1992) to Council Directive 

67/548/EEC (27 June 1967). It was carried out in accordance with the principles set 

out in the European Commission Directive 93/67/EEC (20 July 1993) for substances 

notified in accordance with Council Directive 67/548/EEC (27 June 1967). 

• This substance will not be manufactured or processed in the European Union 

(EU). The substance will be imported as a component of mixtures. The mixtures 

are ; used in a commercial The mixtures will contain 0.1-8.0% 

of the substance in water. 

• The mixtures will be imported in 500 ml quantities packaged in plastic bottles. 

The bottles of will be packaged in cardboard boxes which will also contain an 

empty _ and siphon. The user of the will load the into the 

using the siphon. 

• The acute oral LD5o is >2000 mg/kg. 

• Based on a review of the health, physicochemical, and environmental 

assessments, the conclusion at Article 3(4)(i) shall apply: "The substance is of no 

immediate concern and need not be consi~red again until further information is 

made available in accordance with Article 7(2), 8(3), 8(4) or 14(1) of Directive 

67/548/EEC." 

-iii-

/()..3 
COMMERCIAL-IN-CONFIDENCE 

RISK ASSESSMENT 

(____ _ 

1.0 INTRODUCTION CONFIDENTIAL 

This assessment of the potential risk to man and the environment for 

(_ )/vas conducted in 

support of the submitter's new chemical notification as specified in the Seventh 

Amendment, Articles 1 (1 c), 3 and 7 (92/32/EEC, 30 April 1992) to Council Directive 

67/548/EEC (27 June 1967). The regulations stipulate that the member state 

Competent Authority carry out a risk assessment for new substances. 

Manufacturers and importers are free to conduct the assessment and include it with 

the submission of the notification and are encouraged to do so using the principles 

for assessment of risks to man and the environment specified in Commission 

Directive 93/67/EEC (20 July 1993) for substances notified in accordance with 

Council Directive 67/548/EEC (27 June 1967). It is recognized that the basis for 

this risk assessment and the recommendations provided by the submitter are 

subject to the scrutiny of the Competent Authority to whom the notification is 

submitted. 

The format of the following assessment is outlined in the Commission Directive 

93/67/EEC, (20 July 1993) with greater detail provided in guidelines entitled "Risk 

Assessment for New Notified Substances and Risk Assessment for Existing 

Substances" issued by the European Commission (DG XI), lspra, Italy, 19th April, 

1996. 

This substance will not be manufactured or processed in the European Union (EU). 

It will be imported as a component in mixtur~. The mixtures will contain 0.1-8.0% 

of the substance in water. The mixtures will be imported in 500 ml quantities 

packaged in plastic bottles. The bottles will be packaged in cardboard boxes which 

will also contain an empty siphon and 

The mixtures will be used in a commercial The 

expected to be used in commercial applications. No consumer or general public 

usage is expected. 

is 

Since this substance will be imported as a component of mixtures, no release to the 

environment during manufacture will take place. No release to the environment is 

expected during normal use or processing. 

-1-
COMMERCIAL-IN-CONFIDENCE (_- - ) 

2.0 HEALTH ASSESSMENT- TOXICITY 

2.1 HAZARD IDENTIFICATION fONFIDENTIAL 

2.1 .1 Toxicity Data from Animal Studies: 

2.1.1.1 Acute Toxicity: 

Acute Oral Toxicity: The oral LDso value for male and female rats 

is greater than 2000 mg/kg. 

Acute Dermal Toxicity: Test not conducted. 

2.1.1.2 Irritation and Sensitization: 

Acute Derma/Irritation: Test not conducted. 

Acute Eve Irritation: Test not conducted. 

Skin Sensitization (Buehler Test): Test not conducted. 

2.1.2 Mutagenicity: 

Salmonella tVPhimurium -Escherichia colt. Test not conducted. 

Chinese Hamster Ovarv (CHO) Cell Chromosomal Aberration: 

Test not conducted. 

2.1.3 Carcinogenicity: 

No bioassay studies have been conducted. 

2.1.4 Reproductive Toxicity: 

No reproductive toxicity studies have been conducted. 

2.1.5 Repeated Dose Toxicity: 

No repeated dose toxicity studies have been conducted. 

2.1.6 Toxicity Data from Human Studies: 

No data are available from human studies. 

2.2 DOSE-RESPONSE ASSESSMENT 

No hazard was identified and therefore no dose response assessment 

is necessary. 

2.3 EXPOSURE ASSESSMENT 

2.3.1 Introduction: 

There are no data available on human exposure to the substance. 

The substance is in the mixture at ranges between 0.1 and 8%. 

-2-

}56 
2.3.2 

2.3.3 

2.3.4 

fONFIDENTJAL 

Occupational Exposure: 

No occupational exposure is expected 

COMMERCIAL-IN-CONFIDENCE 

to the substance. 

~ 

Consumer Exposure: 

Since it is assumed that these inks are not expected to be present in 

devices available for consumer use, no exposure to consumers is 

expected. Therefore, no further assessment was conducted. 

Public Exposure: 

No exposure to the public is expected. Therefore, no further 

assessment was conducted. 

2.4 RISK CHARACTERIZATION 

2.4.1 Classification Review: 

The guidelines for determining whether classification is needed 

appear in Council Directive 92/32/EEC Annex 2 (General 

Classification and Labeling Requirements for Dangerous 

Substances). The LDso value for male and female rats is greater 

than 2000 mg/kg. No classifiable effect as identified in 92/32/EEC 

(ANNEX 2) was observed. 

2.5 INTEGRATION 

No hazard has been identified in the health assessment of this substance. 

The substance will be imported as a component of mixtures (inks). No 

public or consumer exposure to the substance is expected from the use of 

these inks. Therefore the conclusion,at Article 3(4)(i) shall apply: "The 

substance is of no immediate concern and need not be considered again 

until further information is made available in accordance with Article 7(2), 

8(3), 8(4) or 14(1) of Directive 67/548/EEC." 

3.0 HEALTH ASSESSMENT- PHYSICOCHEMICAL PROPERTIES 

3.1 HAZARD IDENTIFICATION 

3.1.1 Flammability (Solids): Not highly flammable 

Other available data: 

Stability (Thermal Stability as Measured by Differential Scanning 

Calorimetry (DSC) under Nitrogen): Exotherm of 49 J/g with an onset 

temperature of 346°C (See Attachment 1 ). 

-3-

15& 
3.2 

COMMERCIAL-IN?""NEIDENCE 

( ______ ) 

EXPOSURE ASSESSMENT CONFIDENTIAL 

3.2.1 Flammability (Solids) 

Not applicable, since this physicochemical hazard identification 

study did not result in classification of the substance. 

3.2.2 Stability as Measured by DSC: 

The substance is not classifiable based on the test result, since there 

are no criteria for classifying substances as dangerous based on this 

test. However, the physicochemical properties identified should pose 

no significant exposure potential in transportation, storage, handling, 

product manufacturing, or customer use based on the stability as 

measured by DSC. 

3.3 RISK CHARACTERIZATION 

The required hazard identification study has been conducted and the 

result has not led to the classification of the substance. In accordance 

with Article 4(2)(i) of Commission Directive 93/67/EEC, if the substance 

is not classified by any of the required tests, then a risk characterization 

is not necessary and the conclusion at Article 3(4)(i) shall apply: "The 

substance is of no immediate concern and need not be considered again 

until further information is made available in accordance with Article 7(2), 

8(3), 8(4) or 14(1) of Directive 67/548/EEC. 

3.4 INTEGRATION 

No significant risk has been identi.Ued in the physicochemical properties 

assessment of this substance. Therefore, the conclusion at Article 3(4)(i) 

shall apply: "The substance is of no immediate concern and need not be 

considered again until further information is made available in accordance 

with Article 7(2), 8(3), 8(4) or 14(1) of Directive 67/548/EEC." 

4.0 ENVIRONMENTAL ASSESSMENT 

4.1 HAZARD IDENTIFICATION 

4.1 .1 Toxicity Data: 

Environmental effects or fate testing is not required at this level of 

notification. 

4.2 DOSE-RESPONSE ASSESSMENT 

Since no ecotoxicological tests are required to support a VIIC notification, a 

quantitative dose-response assessment is not applicable. 

-4-

/57 
CONFIDENTIAL COMMERCIAL-IN-CONFIDENCE L ____ _ 

4~ EXPOSUREASSESSMENT 

This substance will not be manufactured or processed in the EU. Up to 100 

kg of the substance will be imported into the European Union. During 

the intended use of the substance, there will be no release to the 

environment. Very small amounts of the substance will remain in bottles 

after use. These bottles are expected to be disposed of at landfills. 

4.4 RISK CHARACTERIZATION 

Although a quantitative PEC/PNEC ratio cannot be calculated from the 

data available at this time, the potential for adverse effects is very low based 

on import volume and anticipated use. Based on the available test data and 

information, the conclusion from Commission Directive 93/67/EEC, Article 3 

(4) (i) shall apply, "The substance is of no immediate concern and need not 

be considered again until further information is available in accordance with 

Article 7(2), 8(3), 8(4) or 14(1) of Directive 67/548/EEC." 

4.5 INTEGRATION 

Not applicable at this level. 

5.0 OVERALL INTEGRATION OF CONCLUSIONS 

The Health, Environmental and Physical/Chemical Property Assessments 

suggest low risk from the use of this substance. The assessments suggest 

that the following conclusion from Article 3(4)(i) of Commission Directive 

93/67/EEC (20 July 1993) shall apply: "The substance is of no immediate 

concern and need not be considered again until further information is 

available in accordance with Article 7,(2), 8(3), 8(4) or 14(1) of Directive 

67/548/EEC." 

-5-

/58 
COMMERCIAL-IN-CONFIDENCE 

Health and Environment Laboratories 

Eastman Kodak Company 

1100 Ridgeway Avenue 

Rochester, New York 14652-6267 

U.S.A. 

APPROVAL 

PREPARED BY: 

Group Leader, Research and Development Support Group 

Julie Byrne/Ruth Hosenfeld 

30 September 1998 

al & Regulatory Information 

-6-

/b9 

fONHDENTIAl 

:s~ ~--er. /~9r 

Date 

. l 

s-~i:1D' Date 

~or+ 9P 

Date 
Sample: 

Size: 1. 0700 mg 

Method: 25-420 GC SEAL 10C/MIN N2 

-

3: 

E 

........ 

:r 

0 

r-1 

IJ.. 

....._ +J 

3 

2 

1 

0 

-1 ()I 

-2 

-3 

93.27°C 

60.30J/g 

99.04°C 

Residue: BLACK 

-4 ' - . 

40 -- i'fO ,. 160. Approved By: -. ) . . .-(' cc. · , . / _i_! ' iTested 8 y : ££02 K h.a2uy .2.1 .l:LI _11 

DSC 

200 240 

Tempera-ture 

' TSL 

File: C: E981279 .00

Operator: P. KINGS

Run Date: 6-Jul-98 

280 

( oc) 

Melt c Ex

373.6

370. 15°C 

48.47J/g 

Rate = 0 

A*E = 27

dT/dt = 

320 360 

T

OSC-Auto